Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FOS · Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
150 daysmedian FDA review time
227 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | 2021-05-06 | 318 | 0 |
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 | 30 | 3 |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | Footprint Medical, Inc. | 2012-03-01 | 29 | 0 |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | Footprint Medical | 2009-09-25 | 151 | 0 |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | Footprint Medical | 2009-09-25 | 151 | 0 |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC | Neomed, Inc. | 2008-07-21 | 52 | 0 |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Neomed, Inc. | 2008-02-22 | 63 | 0 |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | Schiff & Co. | 1998-10-01 | 147 | 0 |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | 1996-12-24 | 82 | 0 |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CA | Sherwood Medical Co. | 1995-12-13 | 90 | 0 |
| K951738 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1995-09-29 | 168 | 1 |
| K951737 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSER | Sherwood Medical Co. | 1995-09-28 | 167 | 1 |
| K942353 | CENTURION UMBILICAL CATHETER | Tri-State Hospital Supply Corp. | 1995-08-15 | 455 | 0 |
| K941429 | IV CATHETER AND OBTURATOR | Becton Dickinson Vascular Access, Inc. | 1995-01-04 | 286 | 0 |
| K942827 | SENTRY INSERTION TRAY | Sentry Medical Products, Inc. | 1994-11-02 | 141 | 0 |
| K941814 | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1994-09-30 | 171 | 1 |
| K942564 | ARGYLE NEO-SERT | Sherwood Medical Co. | 1994-08-25 | 86 | 0 |
| K940953 | UMBILI-CATH-S | Gesco Intl., Inc. | 1994-08-02 | 154 | 0 |
| K940870 | UMBILI-CATH | Gesco Intl., Inc. | 1994-08-02 | 158 | 0 |
| K940952 | UMBILI-CATH-S-DL | Gesco Intl., Inc. | 1994-07-29 | 150 | 0 |
| K940871 | UMBILI-CATH-P | Gesco Intl., Inc. | 1994-04-29 | 63 | 0 |
| K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | Vygon Corp. | 1992-10-26 | 221 | 0 |
| K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | Vygon Corp. | 1992-10-26 | 221 | 0 |
| K911607 | GESCO UMBILI-CATH | Gesco Intl., Inc. | 1991-06-11 | 62 | 0 |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Gesco Intl., Inc. | 1990-04-17 | 182 | 0 |
| K890685 | BARD UMBILICAL VESSEL CATHETER | C.R. Bard, Inc. | 1989-02-28 | 19 | 0 |
| K850884 | ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1985-10-17 | 227 | 0 |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | Vygon Corp. | 1985-05-21 | 70 | 0 |
| K840339 | UMBILICAL VESSEL CATHETER | Catheter Technology Corp. | 1984-07-25 | 182 | 0 |
| K831988 | INTRAVASCULAR CATHETER | C.R. Bard, Inc. | 1983-11-08 | 140 | 0 |
| K802414 | UMBILI-CATH CATHETER | Int'L Corp. | 1980-10-23 | 20 | 0 |
| K771022 | CATHETER, UMBILICAR ARTERY | Axiom Medical, Inc. | 1977-11-29 | 176 | 0 |
| K771891 | CATHETER, UMBILICAL, VICRA | Travenol Laboratories, S.A. | 1977-11-02 | 27 | 0 |
| K760966 | CATHETER, UMBILICAL ARTERY | Sherwood Medical Industries | 1977-01-26 | 83 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda