Atlas FDA

KMK

64 FDA 510(k) clearances · Product code

79 daysmedian time to decision
209 days90th percentile
64clearances measured

FDA profile

Official device name
Device, Intravascular Catheter Securement
Device class
Class I (low risk)
Regulation
21 CFR 880.5210
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 33 · 2022: 103 · 2023: 138 · 2024: 104 · 2025: 75 · 2026: 49
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994)Interrad Medical, Inc.2019-07-09
A P HARNESS (K981860)Paraworks Enterprise, Ltd.1999-06-03
MULTI-PURPOSE MEDICAL TUBE HOLDER (K963365)Byrd Medical Devices, Inc.1996-10-11
SECURE-SITE (K941098)Op-Co Medical Products , Ltd.1995-08-09
STATLOCK CV (K943147)Venetec, Inc.1994-09-29
IV START KITS (K943047)Sterile Concepts, Inc.1994-09-14
IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940)Tnt Moborg Intl. , Ltd.1994-07-14
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (K941850)Tnt Moborg Intl. , Ltd.1994-07-14
CONMED VENI-GARD I.V. DRESSING (K935389)Conmedcorp1994-03-07
K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (K935252)K-Lok, Inc.1994-02-18
CENTERMARK SECURING WINGS (K940127)Menlo Care, Inc.1994-02-09
SECURODRIP (TM) I.V. ARMBOARD (K932757)Op-Co Medical Products , Ltd.1993-12-08
DUODERM TRANSPARENT HYDROCOLLOID DRESSING (K925992)Convatec, A Division of E.R. Squibb & Sons1993-10-15
IV COMFORT PAD (K930663)D.J. Scott Mfg., Inc.1993-09-30
IAB ANCHOR (K922103)Datascope Corp.1993-08-03
K-LOK CATHETER SECUREMENT DEVICE (K930225)K-Lok, Inc.1993-04-21
KWIK BOARD (K930197)Astral, Ltd.1993-04-20
I.V. PRO (K924180)I.V. - Pro Tek, Inc.1993-03-16
ILS(TM) - INVASIVE LINE SEPARATOR (K924369)2-Rn Corp.1993-02-05
DERMASSIST TRANSPARENT SITE DRESSING (K924249)Wilshire Medical Products1993-02-03
TRACE MODEL# 840, 841,842 & 845 ARM BOARD (K925502)Trace Medical Equipment, Inc.1993-01-12
RESTRAINT, PROTECTIVE N0. 103 (K924566)Ansley Medical Products, Inc.1992-11-23
TUBE, LEAD, AND CORD HOLDER NO. 102 (K924568)Ansley Medical Products, Inc.1992-11-23
FOLEY CATHETER TUBE HOLDER NO. 101 (K924567)Ansley Medical Products, Inc.1992-11-23
DESERET POSITIONAL SUTURE WING (K915495)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-06
SECURODRIP (K912660)Op-Co Medical Products , Ltd.1991-12-04
IV HOUSE (K912942)Progressive Iv'S, Inc.1991-09-25
INTRAVASCULAR CATHETER SECURMENT DEVICE (K912211)Inman Liebelt Corp.1991-08-09
PICC-FIX (K911070)Sorex Medical1991-07-05
COMFOR-BOARD (K910880)Medway1991-06-06
GENNY DENNY IV SHIELD (K905735)Tadco, Inc.1991-01-18
BABY BOARDS IV SUPPORT ASSEMBLY (K900134)Baby Boards, Inc.1990-07-09
TRANSPARENT FILM I.V. SITE/WOUND DRESSING (K896421)Catalina Biomedical Corp.1990-01-31
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE (K896046)Vitaphore Corp.1990-01-11
VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (K895993)Vitaphore Corp.1990-01-11
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE (K895431)Johnson & Johnson Patient Care, Inc.1989-10-13
DALE I.V. IDENTIFIER; PRODUCT #1125 (K894586)Dale Medical Products, Inc.1989-08-15
DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 (K873311)Dale Medical Products, Inc.1987-11-05
TIMLEINE(TM) VENIPUNCTURE SYSTEM (K870770)Ipax, Inc.1987-04-23
E-Z HOLD - #4060 (K864190)John F. Greer Co., Inc.1987-01-14
IV BAND (INTRAVENOUS CATHETER ASSESORY) (K860706)T. G. & E. Medical1986-03-21
HOLD-IT FRAMED ADHESIVE FILM (K860071)Vlv Associates, Inc.1986-01-27
I.V. DRESSING (K854040)Consolidated Medical Equipment, Inc.1986-01-09
SAFTI-BRACELET (K853418)Advanced Biosearch Assn.1985-09-20
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS (K850503)Turn Needle Intl., Inc.1985-04-01
TRENDS LANCET (K843882)Orange Medical Instruments, Inc.1984-11-05
VENI-SHIELD (K842999)U.S. Mfg. & Management, Inc.1984-09-24
ACU-DERM TRANSPARENT IV DRESSING (K842064)Acme United Corp.1984-08-15
INTRAVASCULAR CATHETER SECUREMENT DEV (K841487)Tapemark Co.1984-06-28
FPP IV SECURE (K840683)Fpp, Inc.1984-03-06
I.V. FILTER HOLDER (K832300)Saxnor Corp.1983-10-04
FREHAN INC. I.V. FILTER HOLDER (K830300)Saxnor Corp.1983-03-01
LINEGUARD CATHETER SHIELD MODEL 100 (K822732)Ray-Marshall Laboratory1982-09-24
CATH-LOK (K821957)Hpd Medical, Inc.1982-07-28
EZ-FIX I.V. CATHETER HOLDER (K821796)Dyna Care1982-06-24
UNIVERSAL I.V. HOLDER (K821317)Georgetown Medical Co.1982-05-28
VEIN-SHIELD (K820759)Pan-Tech Research, Inc.1982-05-14
AEGIS I.V. STRIPS (K812080)Warner-Lambert Co.1981-08-03
ADHESIVE I.V. CATHETER DRESSING (K810579)Johnson & Johnson Professionals, Inc.1981-03-26
EYEWI ANKORS (K800726)Eyevi & Co.1980-05-08
I.V. TAPE DOWN HOLDER (K800024)Consolidated Medical Equipment, Inc.1980-01-29
I.V. STRIP (K792049)E-Med Corp.1979-11-20
GRIP, HOSPITAL UTILITY (K781800)Baka Manufacturing Co., Inc.1978-12-07
I.V. LOK TM (K770119)Jelco Laboratories1977-03-14

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Every clearance here is in the API, with alerts when new ones post.