BEUDAMED
    Product Code: OMP FDA class 2 21 CFR 878.4780

    Negative Pressure Wound Therapy Powered Suction Pump

    General, Plastic Surgery

    The Negative Pressure Wound Therapy Powered Suction Pump (product code OMP) is a Class 2 surgical device regulated under 21 CFR 878.4780 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is indicated for wound management by applying continual or intermittent negative pressure to remove fluids from chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (including diabetic and pressure ulcers), and flaps and grafts. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    205
    FEI Numbers
    96
    Registration Numbers
    96
    Unique Applicants
    87
    Years Active
    28

    Basic Information

    Product Code
    OMP
    Device Class
    FDA class 2
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 205 510(k) clearances via K numbers.

    K Number Device Name
    K243187 Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
    K243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
    K233614 Genadyne DUO NPWT
    K241061 VERSA Negative Pressure Wound Therapy System (VCMPP-100)
    K241023 Negative Pressure Wound Therapy Device (V-Move, V-Grand)
    K241515 NEXA™ NPWT System
    K231939 Renasys Edge
    K241134 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
    K230233 Prospera Spectruum Negative Pressure Wound Therapy System
    K231646 Carilex VT¿200-i NX
    K232379 PREVENT Kit
    K230677 Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
    K223388 Invia® Integrated Dressing
    K221888 Genadyne Hybrid Foam Dressings
    K222859 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
    K221585 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
    K213906 extriCARE 1000 Negative Pressure Wound Therapy System
    K213853 RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
    K221223 extriCARE® 3000 Negative Wound Pressure Therapy System
    K221891 UNO Negative Pressure Wound Therapy System
    K223041 Renasys Edge (66803126)
    K212359 PWD Negative Pressure Wound Therapy System
    K214112 Invia Ease Negative Pressure Wound Therapy (NPWT) System
    K220560 Dermatac Drape
    K220660 Prevena Restor Adapti-Form Dressing
    K210107 Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
    K211571 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
    K202783 Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
    K211318 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
    K202898 Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
    K211521 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
    K211277 Theia NPWT Foam Wound Dressing Kit
    K202823 Innomed NPWT Silicone Foam Dressing
    K203316 V.A.C.ULTA Negative Pressure Wound Therapy System
    K212320 Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
    K203693 Nisus Touch Negative Pressure Wound Therapy Pump
    K203369 Avance Solo Negative Pressure Wound Therapy (NPWT) System
    K202217 Kendall NPWT Incision Management Device
    K202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
    K200223 PocketDoc™ Micro Wound Therapy System
    K191101 Kendall NPWT Incision Management Dressing Kit
    K201571 ACTIV.A.C. Negative Pressure Wound Therapy System
    K200390 V.A.C. DERMATAC Drape
    K190028 UNO 30
    K191760 PICO 14 Single Use Negative Pressure Wound Therapy System
    K190697 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
    K190119 Foryou NPWT Dressing Kit
    K182722 XLR8 Abdominal Wound Dressing Kit
    K191460 PWD Platform Wound Dressing 3” x 5” Oblong
    K182458 Longterm NPWT Foam Dressing Kit
    K181505 V.A.C. DERMATAC Drape
    K181929 MiMo(TM) Negative Pressure Wound Therapy System
    K181822 RENASYS Touch; RENASYS Y-Connector
    K183543 ACTIV.A.C. Therapy Unit
    K181507 PREVENA RESTOR(TM) Incision Management System
    K182191 Invia Abdominal Dressing Kit
    K182323 PICO 7Y Single Use Negative Pressure Wound Therapy System
    K182409 Applied Tissue Technologies PWD™ Platform Wound Dressing
    K181204 RENASYS Y-Connector; RENASYS TOUCH
    K180840 UNO Negative Pressure Wound Therapy System
    K180415 Invia White Foam NPWT
    K180205 AVELLE Negative Pressure Wound Therapy System
    K180698 PICO 7 Single Use Negative Pressure Wound Therapy System
    K173407 VT - 100, VT - 200
    K172725 VT Dressing Kits
    K180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
    K172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
    K180618 PICO Single Use Negative Pressure Wound Therapy System
    K180614 PICO Single Use Negative Pressure Wound Therapy System
    K173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
    K173447 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
    K172005 PICO 7 Single Use Negative Pressure Wound Therapy System
    K171499 Occlusion Detection Dressing Kit
    K172521 PICO Single Use Negative Pressure Wound Therapy System
    K172519 PICO Single Use Negative Pressure Wound Therapy System
    K162610 NEXA Negative Pressure Wound Therapy System
    K162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
    K163387 PICO Single Use Negative Pressure Wound Therapy System
    K170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
    K161599 UNO Negative Pressure Wound Therapy System
    K161432 MyNeWT Negative Pressure Wound Therapy System
    K162790 V.A.C.ULTA Negative Pressure Wound Therapy System
    K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
    K160487 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
    K161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
    K150960 WoundPro Negative Pressure Wound Therapy System
    K161935 Avance Foam Dressing Kit - XL
    K161948 Avance Gauze Dressing Kits
    K161797 Avance Tubing, Avance Y-Connector, Avance ViewPad
    K161410 VT·One, VT·One 60days
    K161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
    K152163 RENASYS GO
    K162129 RENASYS-G Gauze Dressing Kits with Soft Port
    K161570 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
    K153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
    K160451 V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
    K153199 Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
    K151263 Venturi Gauze Wound Care Sets with Portal Drain
    K151436 PICO Single Use Negative Pressure Wound Therapy System
    K152741 Mepiseal Soft Silicone Sealant
    K150459 FloSure Ventilation Patch
    K143004 VENTURI MiNO TG600/14
    K150006 Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
    K151872 Avance Y-Connector S
    K151261 Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large
    K150124 Cardinal Health NPWT PRO HC
    K141017 PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
    K143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
    K151326 RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
    K143726 XLR8 PLUS (XLR8+)
    K142626 Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
    K151240 extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
    K142385 Whisper Pump System
    K142646 XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
    K142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
    K143016 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
    K141961 GENADYNE SPIRO FOAM DRESSING KIT
    K141847 AVANCE FOAM DRESSING KITS
    K142916 SVED Wound Treatment System
    K143301 NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
    K142956 NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
    K143362 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
    K133333 UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
    K141926 INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K140022 NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
    K141437 XLR8 PLUS (XLR8+)
    K140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
    K141033 SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
    K132225 EXTRICARE
    K132004 NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
    K133232 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
    K132936 NOVOPORE DRESSING
    K133276 V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
    K132741 V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K122490 KULAVAC
    K132446 RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
    K132252 EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
    K121817 VCARE A
    K131464 EXTRICARE NPWT FOOT DRESSING
    K123507 KCI NPWT GAUZE DRESSING
    K113236 FORYOU NPWT DEVICE
    K122132 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
    K123878 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
    K112853 VOLTERA POWERED SUCTION PUMP
    K121883 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
    K120499 ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
    K113678 INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K113291 SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
    K113199 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
    K111949 AC WOUND TREATMENT SYSTEM
    K120033 ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
    K112127 PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K110078 EXTRICARE
    K112458 PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K111170 PICO
    K111333 ANTLIA III WOUND TREATMENT SYSTEM
    K111280 V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
    K110647 RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
    K103156 V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
    K100823 WOUND PRO APEX
    K102956 V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING
    K100657 V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
    K102001 MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
    K092992 A4-XLR8 FOAM DRESSING
    K100821 PREVENA INCISION MANAGEMENT SYSTEM
    K093526 V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
    K091585 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
    K093564 SVED WOUND TREATMENT SYSTEM
    K090258 VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
    K091470 RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
    K090638 GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
    K090130 ATMOS S041 WOUND
    K083357 OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
    K083375 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
    K082676 GENADYNE A4 WOUND VACUUM SYSTEM
    K082415 PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
    K082211 RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
    K080275 NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K082311 EXSUDEX WOUND DRAINAGE PUMP
    K082426 RENASYS EZ
    K080357 MEDELA INVIA WOUND THERAPY
    K080897 VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    K063740 V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
    K063692 V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
    K071301 ANTLIA I WOUND IRRIGATION SYSTEM
    K070904 ANTLIA II SUCTION PUMP SYSTEM
    K061919 VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
    K063590 V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
    K063426 V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
    K062456 NOVASPINE POWERED SUCTION PUMP PRO-1
    K062227 V.A.C. THERAPY SYSTEM
    K061367 BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
    K061788 BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
    K061435 MEDELA VARIO SUCTION PUMPS
    K053627 MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
    K052456 MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
    K050261 V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
    K041642 V.A.C. GRANUFOAM SILVER DRESSING
    K042134 VERSATILE 1 WOUND VACUUM SYSTEM
    K032310 MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
    K032301 NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
    K021500 VACUUM ASSISTED CLOSURE
    K021501 V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
    K992448 V.A.C. PLUS
    K971548 AMBUVAC

    FEI Numbers

    This FDA classification entry is associated with 96 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 96 registration numbers. Click on an entry to view related FDA registrations.