FDA Product Code
FDA Product Code KMK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5210
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | 2019-07-09 | Traditional | PDF ↗ |
| K981860 | A P HARNESS | Paraworks Enterprise, Ltd. | 1999-06-03 | Traditional | PDF ↗ |
| K963365 | MULTI-PURPOSE MEDICAL TUBE HOLDER | Byrd Medical Devices, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K941098 | SECURE-SITE | Op-Co Medical Products , Ltd. | 1995-08-09 | Traditional | PDF ↗ |
| K943147 | STATLOCK CV | Venetec, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K943047 | IV START KITS | Sterile Concepts, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K941940 | IMMOBILE STERILE AND IMMOBILE A/C STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 | Traditional | PDF ↗ |
| K941850 | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 | Traditional | PDF ↗ |
| K935389 | CONMED VENI-GARD I.V. DRESSING | Conmedcorp | 1994-03-07 | Traditional | PDF ↗ |
| K935252 | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | K-Lok, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K940127 | CENTERMARK SECURING WINGS | Menlo Care, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K932757 | SECURODRIP (TM) I.V. ARMBOARD | Op-Co Medical Products , Ltd. | 1993-12-08 | Traditional | PDF ↗ |
| K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1993-10-15 | Traditional | PDF ↗ |
| K930663 | IV COMFORT PAD | D.J. Scott Mfg., Inc. | 1993-09-30 | Traditional | PDF ↗ |
| K922103 | IAB ANCHOR | Datascope Corp. | 1993-08-03 | Traditional | PDF ↗ |
| K930225 | K-LOK CATHETER SECUREMENT DEVICE | K-Lok, Inc. | 1993-04-21 | Traditional | PDF ↗ |
| K930197 | KWIK BOARD | Astral, Ltd. | 1993-04-20 | Traditional | PDF ↗ |
| K924180 | I.V. PRO | I.V. - Pro Tek, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K924369 | ILS(TM) - INVASIVE LINE SEPARATOR | 2-Rn Corp. | 1993-02-05 | Traditional | PDF ↗ |
| K924249 | DERMASSIST TRANSPARENT SITE DRESSING | Wilshire Medical Products | 1993-02-03 | Traditional | PDF ↗ |
| K925502 | TRACE MODEL# 840, 841,842 & 845 ARM BOARD | Trace Medical Equipment, Inc. | 1993-01-12 | Traditional | PDF ↗ |
| K924567 | FOLEY CATHETER TUBE HOLDER NO. 101 | Ansley Medical Products, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K924568 | TUBE, LEAD, AND CORD HOLDER NO. 102 | Ansley Medical Products, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K924566 | RESTRAINT, PROTECTIVE N0. 103 | Ansley Medical Products, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K915495 | DESERET POSITIONAL SUTURE WING | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-06 | Traditional | PDF ↗ |
| K912660 | SECURODRIP | Op-Co Medical Products , Ltd. | 1991-12-04 | Traditional | PDF ↗ |
| K912942 | IV HOUSE | Progressive Iv'S, Inc. | 1991-09-25 | Traditional | PDF ↗ |
| K912211 | INTRAVASCULAR CATHETER SECURMENT DEVICE | Inman Liebelt Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K911070 | PICC-FIX | Sorex Medical | 1991-07-05 | Traditional | PDF ↗ |
| K910880 | COMFOR-BOARD | Medway | 1991-06-06 | Traditional | PDF ↗ |
| K905735 | GENNY DENNY IV SHIELD | Tadco, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K900134 | BABY BOARDS IV SUPPORT ASSEMBLY | Baby Boards, Inc. | 1990-07-09 | Traditional | PDF ↗ |
| K896421 | TRANSPARENT FILM I.V. SITE/WOUND DRESSING | Catalina Biomedical Corp. | 1990-01-31 | Traditional | PDF ↗ |
| K895993 | VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE | Vitaphore Corp. | 1990-01-11 | Traditional | PDF ↗ |
| K896046 | VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE | Vitaphore Corp. | 1990-01-11 | Traditional | PDF ↗ |
| K895431 | JOHNSON & JOHNSON TUBE SECUREMENT DEVICE | Johnson & Johnson Patient Care, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | Dale Medical Products, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | Dale Medical Products, Inc. | 1987-11-05 | Traditional | PDF ↗ |
| K870770 | TIMLEINE(TM) VENIPUNCTURE SYSTEM | Ipax, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K864190 | E-Z HOLD - #4060 | John F. Greer Co., Inc. | 1987-01-14 | Traditional | PDF ↗ |
| K860706 | IV BAND (INTRAVENOUS CATHETER ASSESORY) | T. G. & E. Medical | 1986-03-21 | Traditional | PDF ↗ |
| K860071 | HOLD-IT FRAMED ADHESIVE FILM | Vlv Associates, Inc. | 1986-01-27 | Traditional | PDF ↗ |
| K854040 | I.V. DRESSING | Consolidated Medical Equipment, Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K853418 | SAFTI-BRACELET | Advanced Biosearch Assn. | 1985-09-20 | Traditional | PDF ↗ |
| K850503 | SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS | Turn Needle Intl., Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K843882 | TRENDS LANCET | Orange Medical Instruments, Inc. | 1984-11-05 | Traditional | PDF ↗ |
| K842999 | VENI-SHIELD | U.S. Mfg. & Management, Inc. | 1984-09-24 | Traditional | PDF ↗ |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | Acme United Corp. | 1984-08-15 | Traditional | PDF ↗ |
| K841487 | INTRAVASCULAR CATHETER SECUREMENT DEV | Tapemark Co. | 1984-06-28 | Traditional | PDF ↗ |
| K840683 | FPP IV SECURE | Fpp, Inc. | 1984-03-06 | Traditional | PDF ↗ |
| K832300 | I.V. FILTER HOLDER | Saxnor Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K830300 | FREHAN INC. I.V. FILTER HOLDER | Saxnor Corp. | 1983-03-01 | Traditional | PDF ↗ |
| K822732 | LINEGUARD CATHETER SHIELD MODEL 100 | Ray-Marshall Laboratory | 1982-09-24 | Traditional | PDF ↗ |
| K821957 | CATH-LOK | Hpd Medical, Inc. | 1982-07-28 | Traditional | PDF ↗ |
| K821796 | EZ-FIX I.V. CATHETER HOLDER | Dyna Care | 1982-06-24 | Traditional | PDF ↗ |
| K821317 | UNIVERSAL I.V. HOLDER | Georgetown Medical Co. | 1982-05-28 | Traditional | PDF ↗ |
| K820759 | VEIN-SHIELD | Pan-Tech Research, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K812080 | AEGIS I.V. STRIPS | Warner-Lambert Co. | 1981-08-03 | Traditional | PDF ↗ |
| K810579 | ADHESIVE I.V. CATHETER DRESSING | Johnson & Johnson Professionals, Inc. | 1981-03-26 | Traditional | PDF ↗ |
| K800726 | EYEWI ANKORS | Eyevi & Co. | 1980-05-08 | Traditional | PDF ↗ |
| K800024 | I.V. TAPE DOWN HOLDER | Consolidated Medical Equipment, Inc. | 1980-01-29 | Traditional | PDF ↗ |
| K792049 | I.V. STRIP | E-Med Corp. | 1979-11-20 | Traditional | PDF ↗ |
| K781800 | GRIP, HOSPITAL UTILITY | Baka Manufacturing Co., Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K770119 | I.V. LOK TM | Jelco Laboratories | 1977-03-14 | Traditional | PDF ↗ |
Product code KMK · Class I · General Hospital. Data: openFDA.