Product Code: KMK FDA class 1 21 CFR 880.5210

Device, Intravascular Catheter Securement

General Hospital

An Intravascular Catheter Securement Device is used to stabilize and secure indwelling intravascular catheters at the insertion site, reducing catheter movement, dislodgement, and related complications such as phlebitis and catheter-associated infections. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KMK and it is regulated under 21 CFR 880.5210 in the General Hospital specialty.

View on FDA

510(k)s

FEI Numbers

194

Registration Numbers

194

Unique Applicants

Years Active

Basic Information

Product Code: KMK
Device Class: FDA class 1
Regulation Number: 880.5210
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K180994	SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F	Jul 09, 2019	Substantially Equivalent	Interrad Medical, Inc.
K981860	A P HARNESS	Jun 03, 1999	Substantially Equivalent	Paraworks Enterprise, Ltd.
K963365	MULTI-PURPOSE MEDICAL TUBE HOLDER	Oct 11, 1996	Substantially Equivalent	Byrd Medical Devices, Inc.
K941098	SECURE-SITE	Aug 09, 1995	Substantially Equivalent	Op-Co Medical Products , Ltd.
K943147	STATLOCK CV	Sep 29, 1994	Substantially Equivalent	Venetec, Inc.
K943047	IV START KITS	Sep 14, 1994	Substantially Equivalent	Sterile Concepts, Inc.
K941940	IMMOBILE STERILE AND IMMOBILE A/C STERILE	Jul 14, 1994	Substantially Equivalent	Tnt Moborg Intl. , Ltd.
K941850	IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE	Jul 14, 1994	Substantially Equivalent	Tnt Moborg Intl. , Ltd.
K935389	CONMED VENI-GARD I.V. DRESSING	Mar 07, 1994	Substantially Equivalent	Conmedcorp
K935252	K-LOK CATHETER SECUREMENT DEVICE MODIFICATION	Feb 18, 1994	Substantially Equivalent	K-Lok, Inc.
K940127	CENTERMARK SECURING WINGS	Feb 09, 1994	Substantially Equivalent	Menlo Care, Inc.
K932757	SECURODRIP (TM) I.V. ARMBOARD	Dec 08, 1993	Substantially Equivalent	Op-Co Medical Products , Ltd.
K925992	DUODERM TRANSPARENT HYDROCOLLOID DRESSING	Oct 15, 1993	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K930663	IV COMFORT PAD	Sep 30, 1993	Substantially Equivalent	D.J. Scott Mfg., Inc.
K922103	IAB ANCHOR	Aug 03, 1993	Substantially Equivalent	Datascope Corp.
K930225	K-LOK CATHETER SECUREMENT DEVICE	Apr 21, 1993	Substantially Equivalent	K-Lok, Inc.
K930197	KWIK BOARD	Apr 20, 1993	Substantially Equivalent	Astral, Ltd.
K924180	I.V. PRO	Mar 16, 1993	Substantially Equivalent	I.V. - Pro Tek, Inc.
K924369	ILS(TM) - INVASIVE LINE SEPARATOR	Feb 05, 1993	Substantially Equivalent	2-Rn Corp.
K924249	DERMASSIST TRANSPARENT SITE DRESSING	Feb 03, 1993	Substantially Equivalent	Wilshire Medical Products
K925502	TRACE MODEL# 840, 841,842 & 845 ARM BOARD	Jan 12, 1993	Substantially Equivalent	Trace Medical Equipment, Inc.
K924568	TUBE, LEAD, AND CORD HOLDER NO. 102	Nov 23, 1992	Substantially Equivalent	Ansley Medical Products, Inc.
K924567	FOLEY CATHETER TUBE HOLDER NO. 101	Nov 23, 1992	Substantially Equivalent	Ansley Medical Products, Inc.
K924566	RESTRAINT, PROTECTIVE N0. 103	Nov 23, 1992	Substantially Equivalent	Ansley Medical Products, Inc.
K915495	DESERET POSITIONAL SUTURE WING	Apr 06, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K912660	SECURODRIP	Dec 04, 1991	Substantially Equivalent	Op-Co Medical Products , Ltd.
K912942	IV HOUSE	Sep 25, 1991	Substantially Equivalent	Progressive Iv'S, Inc.
K912211	INTRAVASCULAR CATHETER SECURMENT DEVICE	Aug 09, 1991	Substantially Equivalent	Inman Liebelt Corp.
K911070	PICC-FIX	Jul 05, 1991	Substantially Equivalent	Sorex Medical
K910880	COMFOR-BOARD	Jun 06, 1991	Substantially Equivalent	Medway
K905735	GENNY DENNY IV SHIELD	Jan 18, 1991	Substantially Equivalent	Tadco, Inc.
K900134	BABY BOARDS IV SUPPORT ASSEMBLY	Jul 09, 1990	Substantially Equivalent	Baby Boards, Inc.
K896421	TRANSPARENT FILM I.V. SITE/WOUND DRESSING	Jan 31, 1990	Substantially Equivalent	Catalina Biomedical Corp.
K896046	VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE	Jan 11, 1990	Substantially Equivalent	Vitaphore Corp.
K895993	VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE	Jan 11, 1990	Substantially Equivalent	Vitaphore Corp.
K895431	JOHNSON & JOHNSON TUBE SECUREMENT DEVICE	Oct 13, 1989	Substantially Equivalent	Johnson & Johnson Patient Care, Inc.
K894586	DALE I.V. IDENTIFIER; PRODUCT #1125	Aug 15, 1989	Substantially Equivalent	Dale Medical Products, Inc.
K873311	DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220	Nov 05, 1987	Substantially Equivalent	Dale Medical Products, Inc.
K870770	TIMLEINE(TM) VENIPUNCTURE SYSTEM	Apr 23, 1987	Substantially Equivalent	Ipax, Inc.
K864190	E-Z HOLD - #4060	Jan 14, 1987	Substantially Equivalent	John F. Greer Co., Inc.
K860706	IV BAND (INTRAVENOUS CATHETER ASSESORY)	Mar 21, 1986	Substantially Equivalent	T. G. & E. Medical
K860071	HOLD-IT FRAMED ADHESIVE FILM	Jan 27, 1986	Substantially Equivalent	Vlv Associates, Inc.
K854040	I.V. DRESSING	Jan 09, 1986	Substantially Equivalent	Consolidated Medical Equipment, Inc.
K853418	SAFTI-BRACELET	Sep 20, 1985	Substantially Equivalent	Advanced Biosearch Assn.
K850503	SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS	Apr 01, 1985	Substantially Equivalent	Turn Needle Intl., Inc.
K843882	TRENDS LANCET	Nov 05, 1984	Substantially Equivalent	Orange Medical Instruments, Inc.
K842999	VENI-SHIELD	Sep 24, 1984	Substantially Equivalent	U.S. Mfg. & Management, Inc.
K842064	ACU-DERM TRANSPARENT IV DRESSING	Aug 15, 1984	Substantially Equivalent	Acme United Corp.
K841487	INTRAVASCULAR CATHETER SECUREMENT DEV	Jun 28, 1984	Substantially Equivalent	Tapemark Co.
K840683	FPP IV SECURE	Mar 06, 1984	Substantially Equivalent	Fpp, Inc.
K832300	I.V. FILTER HOLDER	Oct 04, 1983	Substantially Equivalent	Saxnor Corp.
K830300	FREHAN INC. I.V. FILTER HOLDER	Mar 01, 1983	Substantially Equivalent	Saxnor Corp.
K822732	LINEGUARD CATHETER SHIELD MODEL 100	Sep 24, 1982	Substantially Equivalent	Ray-Marshall Laboratory
K821957	CATH-LOK	Jul 28, 1982	Substantially Equivalent	Hpd Medical, Inc.
K821796	EZ-FIX I.V. CATHETER HOLDER	Jun 24, 1982	Substantially Equivalent	Dyna Care
K821317	UNIVERSAL I.V. HOLDER	May 28, 1982	Substantially Equivalent	Georgetown Medical Co.
K820759	VEIN-SHIELD	May 14, 1982	Substantially Equivalent	Pan-Tech Research, Inc.
K812080	AEGIS I.V. STRIPS	Aug 03, 1981	Substantially Equivalent	Warner-Lambert Co.
K810579	ADHESIVE I.V. CATHETER DRESSING	Mar 26, 1981	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K800726	EYEWI ANKORS	May 08, 1980	Substantially Equivalent	Eyevi & Co.
K800024	I.V. TAPE DOWN HOLDER	Jan 29, 1980	Substantially Equivalent	Consolidated Medical Equipment, Inc.
K792049	I.V. STRIP	Nov 20, 1979	Substantially Equivalent	E-Med Corp.
K781800	GRIP, HOSPITAL UTILITY	Dec 07, 1978	Substantially Equivalent	Baka Manufacturing Co., Inc.
K770119	I.V. LOK TM	Mar 14, 1977	Substantially Equivalent	Jelco Laboratories