BEUDAMED
    Product Code: HGX FDA class 2 21 CFR 884.5160

    Pump, Breast, Powered

    Obstetrics/Gynecology

    The Powered Breast Pump is an electrically operated device used to express breast milk by applying cyclical suction to the nipple, used by lactating women who are unable to breastfeed directly or need to maintain milk supply. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGX, regulated under 21 CFR 884.5160, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    203
    FEI Numbers
    114
    Registration Numbers
    114
    Unique Applicants
    125
    Years Active
    45

    Basic Information

    Product Code
    HGX
    Device Class
    FDA class 2
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 203 510(k) clearances via K numbers.

    K Number Device Name
    K250368 Wearable Breast Pump (Model S21)
    K250365 Motif Aura Glow breast pump (Model Motif Aura Glow)
    K242725 Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
    K243508 Wearable breast pump (model S12A)
    K250829 Lacevo Wearable Breast Pump (Model S70)
    K250152 eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
    K250463 Ameda GLO Wearable Breast Pump (Model W8S)
    K242850 Wearable breast pump (model W8)
    K242111 VIVACE
    K243629 Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
    K241680 Momcozy Wearable Breast Pump (BP311)
    K241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
    K240218 Electric Breast Pump (F5055)
    K242125 Elvie Stride 2
    K241004 Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
    K231969 BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
    K241705 MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)
    K240536 Wearable Breast Pump (Model S32)
    K241506 Annabella Double Breast Pump (ADO-US23-1000)
    K232774 Wearable Breast Pump,Model S18
    K233913 Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
    K232477 Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
    K232608 Duo Hands-free Breast Pump
    K232047 VIVACE
    K233136 Hygeia Express Powered Breast Pump
    K233880 Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
    K231785 Perifit Pump
    K232466 Electric Breast Pump, model: YM-8166
    K230481 Evenflo Premium Double Electric Breast Pump (Model 4018)
    K231595 Electric Breast Pump
    K230570 Willow Generation 3 Breast Pump
    K230102 Smart double sides wearable breast pump, Electric bilateral breast pump
    K230672 Annabella Breast Pump
    K223886 Wearable Breast Pump (Model S18)
    K230469 Compact Wearable Pump
    K230776 Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
    K223329 Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
    K230590 ARDO Bellis
    K223084 MilkMate Breast Pump
    K223693 Electric breast pump (model: M5)
    K222573 imani i2Plus Breast Pump
    K222782 Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
    K222045 Wearable Breast Pump (Model S1DW)
    K222726 Smartpump 3.0 Double Electric Breast Pump
    K221708 CIMILRE Free-T2 Plus
    K220926 Spectra Wearable
    K221598 Wearable breast pump
    K221576 Ameda Pearl Electric Breast Pump
    K211016 Powered Breast Pump (Models 7V and 7X)
    K220309 Wearable Breast Pump (Model S10)
    K220596 Wearable Breast Pump (Model S9)
    K212564 Electric Breast Pump
    K212773 ARDO Alyssa
    K212955 Fit Pro Breast Pump
    K212180 Wearable Breast Pump (Model S12)
    K211024 Electric Breast Pump
    K213311 Lucy Breast Pump
    K212884 Electric breast pump
    K211755 Electric Breast Pump
    K210124 Synergy Gold (SG) Portable (Models MM011450 and MM011460)
    K202802 TT Electric Breast Pump, TT Double Electric Breast Pump
    K210936 Elvie Stride
    K210759 Solo, Swing Maxi
    K203148 Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
    K201152 Electric Breast Pump
    K203570 Mya Joy PLUS Breast Pump
    K201903 Electric breast pump (Models: RH-228 and RH-338)
    K202037 imani i2
    K202045 imani i1
    K200675 Hi bebe super (Models BT-150S and BT-150L)
    K203383 Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
    K201381 Philips Avent Single/Double electric breast pump Advanced
    K193449 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
    K200508 Pump In Style
    K200712 Rumble Tuff Electric Breast Pump
    K192640 Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
    K200406 Evolve Breast Pump
    K191109 Spectra Q
    K191802 Electric Breast Pump
    K190465 Evolve Breast Pump
    K191653 Freestyle Flex
    K191208 Spectra Cashmere
    K191577 Willow Wearable Breast Pump 2.0
    K190810 OPERA, OPERA eco
    K182749 Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
    K182413 Electric Breast Pump
    K181784 Spectra S3 Plus
    K181937 Pump In Style Advanced, Advanced Personal Double Breastpump
    K181863 Elvie Pump
    K180075 MINUET LCD, MINUET LCD eco
    K172842 GCE704 Breast Pump
    K173699 The Pump by Babyation
    K172989 Electric Breast Pump
    K172067 One Mum Pumpset
    K172772 Freemie Independence, Freemie Liberty
    K163183 Yooeehouse Breast Pump
    K170722 Moxxly Flow Collection System
    K163136 Youha electric breast pump
    K162415 Spectra 9Plus
    K162870 CIMLRE F1 and CIMILRE S3
    K162747 Proture Double Electric Breast Pump
    K161725 Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
    K160274 Hi bebe plus
    K161532 Philips Avent Comfort Single/Twin Electric Breast Pump
    K161266 Athena Breast Pump
    K160511 Naya Breast Pump System
    K150476 Spectra S1Plus and Spectra S2 Plus
    K151284 Electric Double Breast Pumps
    K150923 Breast Pump
    K151632 Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
    K150721 ARDO Calypso Pro Powered Breast Pump
    K143585 Electric Breast Pump
    K150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
    K143574 Melodi Prime Breast Pump
    K142479 MEGNA BREAST PUMPS
    K132220 PJ'S SERENITY
    K142168 NATURE'S BOND 600 AND NATURE'S BOND 603
    K141742 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
    K132882 ELECTRIC BREAST PUMP
    K130349 FREEMIE BREAST COLLECTION SYSTEM
    K131153 EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
    K131027 MEMORY PUMP MODEL Y4947
    K121478 NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
    K122474 LANSINOH POWERED ELECTRIC BREAST PUMP
    K113315 RUMBLE TUFF
    K121322 CLOSER TO NATURE
    K112856 LUCINA-MELODI
    K113664 CLOSER TO NATURE ELECTRIC BREAST PUMP
    K111411 FREEMIE (R)
    K102516 LUCINA MODEL MELODI
    K110343 TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
    K102600 SIMPLYGO BREAST PUMP
    K101157 E-BASIC SINGLE BREAST PUMP
    K093145 SPECTRA SERIES BREAST PUMP
    K093648 SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
    K100929 UNIMOM ALLEGRO
    K100435 AMEDA PLATINUM BREAST PUMP
    K100385 NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
    K092783 DEBP
    K092770 SIMPLYGO HANDS FREE BREAST PUMP
    K081463 MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
    K081932 ENDEARE BREAST PUMP
    K082802 MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
    K082307 EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
    K070435 DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
    K061013 PLAYTEX EMBRACE PETITE BREAST PUMP
    K053052 MEDELA SWING BREAST PUMP
    K051926 LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
    K052909 EVENFLO ELAN BREAST PUMP
    K052047 ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
    K051112 WHITTLESTONE EXPRESSER
    K051413 ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
    K043098 GERBER DOUBLE ELECTRIC BREAST PUMP
    K033131 NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
    K032566 NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
    K031614 MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
    K021739 LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
    K022933 EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
    K022594 PLAYTEX BREAST PUMP
    K022140 WHISPER WEAR BREAST PUMP
    K020375 THE NURTURE III BREAST PUMP
    K020518 MEDELA SYMPHONY BREAST PUMP, MODEL 024
    K012275 PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
    K002696 WHITTLESTONE BREASTPUMP
    K981549 LACTATION TECHNIQUES MODEL B
    K983776 EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
    K973501 EXPRESSE AND PREMIER POWERED BREAST PUMPS
    K970488 HYDROCHECK MICRO FILTER
    K971543 LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
    K964679 WHITE RIVER AUTOMATIC BREAST PUMP
    K964396 DOUBLE UP BREAST PUMP
    K960727 EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
    K964403 SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
    K960726 EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
    K952712 WHITE RIVER BATTERY-POWERED BREAST PUMP
    K950750 MEDELAS BREAST PUMP
    K950531 EGNELL ELITE
    K942534 GERBER NATURAL COMFORT BATTERY BREAST PUMP
    K924312 NURTURE III
    K941112 SINGLE HANDED BREAST PUMP
    K936309 DELUXE MAGMAG BREAST PUMP
    K935249 ADVANCED MAGMAG AC/BATTERY BREAST PUMP
    K921261 ELECTRIC POWERED BREAST PUMP
    K901344 MEDELA BATTERY OPERATED BREAST PUMP
    K895114 FRANK MILK PUMP
    K893545 IVEX MODEL NO. BP 3000 BREASTPUMP
    K891996 GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
    K890588 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
    K875300 MEDELA BREAST-PUMP LACTINA
    K874071 MOTHER'S MILK BAG
    K861513 LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
    K853326 WATER DRIVEN BREAST PUMP BY BABY NURSE
    K853107 AXICARE CM-14 AUTOMATIC BREAST PUMP
    K852460 GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
    K850705 THE WHITE RIVER PORTA-ELEC-BREAST PUMP
    K850753 NATURAL MOTHER BREAST PUMP
    K844013 CARE ELECTRIC BREAST PUMP
    K844307 EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
    K842766 CRYSTAL MEDICAL MILK COLLECTION KIT
    K811403 AXICARE BREAST PUMP MODEL
    K810065 SCOTT CM42 PASTEURIZER
    K801862 MEDELA ELECTRIC BREAST PUMP
    K801246 OXFORD HUMAN MILK PASTEURISER

    FEI Numbers

    This FDA classification entry is associated with 114 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 114 registration numbers. Click on an entry to view related FDA registrations.