Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vygon Corp. — Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
390 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121105 | NUTRISAFE 2 FEEDING TUBE | Vygon Corp. | 2012-12-18 | 250 | 0 |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | Vygon Corp. | 2011-10-13 | 631 | 0 |
| K073493 | HEPATOSTAT SET | Vygon Corp. | 2008-05-06 | 146 | 0 |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.0 | Vygon Corp. | 2007-11-30 | 261 | 13 |
| K061796 | HEPATOSTAT SET, MODEL 760X | Vygon Corp. | 2006-11-02 | 129 | 0 |
| K061250 | MULTICATH EXPERT | Vygon Corp. | 2006-09-29 | 148 | 0 |
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER | Vygon Corp. | 2006-09-15 | 28 | 2 |
| K060944 | NUTRISAFE 2 | Vygon Corp. | 2006-09-15 | 162 | 2 |
| K052564 | VYGON LEADER-FLEX | Vygon Corp. | 2006-04-05 | 198 | 0 |
| K052881 | VYGON LATEX FREE BIONECTOR | Vygon Corp. | 2006-03-02 | 141 | 0 |
| K051248 | VYGON MICRO-ACCESS SAFETY INTRODUCER KIT | Vygon Corp. | 2005-10-27 | 164 | 0 |
| K051690 | VYGON NUTRILINE CATHETERS | Vygon Corp. | 2005-08-19 | 57 | 0 |
| K041468 | PREMICATH, 1261.205 | Vygon Corp. | 2004-09-09 | 99 | 1 |
| K003311 | NUTRISAFE PUR ENTERAL FEEDING TUBE | Vygon Corp. | 2002-01-11 | 445 | 0 |
| K010913 | VYGON SPLIT CANNULA INTRODUCER | Vygon Corp. | 2001-09-28 | 185 | 0 |
| K993442 | VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN | Vygon Corp. | 2000-08-03 | 296 | 0 |
| K993052 | VYGON 2 FR EPICUTANEO PUR-CATHETER | Vygon Corp. | 2000-08-03 | 325 | 0 |
| K991918 | NUTRISAFE EXTENSION TUBE | Vygon Corp. | 1999-10-29 | 144 | 2 |
| K983544 | VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) | Vygon Corp. | 1999-01-13 | 96 | 0 |
| K974806 | VYGON NEO-SUMP | Vygon Corp. | 1998-03-23 | 90 | 0 |
| K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | Vygon Corp. | 1997-09-09 | 390 | 0 |
| K963571 | VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR | Vygon Corp. | 1997-06-02 | 270 | 0 |
| K963981 | VYGON BIONECTOR WITH EXTENSION SET | Vygon Corp. | 1997-02-14 | 134 | 14 |
| K954302 | VYGON PREMI-CATH - LONG TERM CATHETER | Vygon Corp. | 1996-06-17 | 278 | 0 |
| K960795 | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE | Vygon Corp. | 1996-05-22 | 85 | 0 |
| K954112 | VYGON LIFEVAC MID-LINE TRAY | Vygon Corp. | 1996-05-09 | 283 | 2 |
| K954638 | 5 FR PICC-LINE CATHETER | Vygon Corp. | 1996-04-22 | 199 | 0 |
| K941678 | BIONECTOR | Vygon Corp. | 1995-06-26 | 447 | 0 |
| K925854 | VYGON - ENTERAL FEEDING TUBE - POLYURETHANE | Vygon Corp. | 1994-05-02 | 531 | 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 |
| K910909 | MUCAID | Vygon Corp. | 1991-05-20 | 76 | 0 |
| K910908 | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING | Vygon Corp. | 1991-05-20 | 76 | 0 |
| K903648 | VYGON LIFEVAC PICC | Vygon Corp. | 1991-03-07 | 206 | 0 |
| K901640 | MULTICATH PLACEMENT KIT | Vygon Corp. | 1990-08-10 | 123 | 0 |
| K896568 | DUALYSE-CATH - CODES #1132.212, 1132.112 | Vygon Corp. | 1990-05-09 | 170 | 0 |
| K897168 | EPICUTANEO-CAVA CATHETER CODE 2184 | Vygon Corp. | 1990-04-23 | 117 | 0 |
| K883612 | LECTROSPIRAL | Vygon Corp. | 1988-09-29 | 38 | 0 |
| K870067 | MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 | Vygon Corp. | 1987-04-28 | 110 | 0 |
| K860285 | XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE | Vygon Corp. | 1986-02-11 | 14 | 0 |
| K851473 | VYGON DELEE SUCTION CATHETER CODE NO 533 | Vygon Corp. | 1985-07-15 | 91 | 0 |
| K851479 | VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193 | Vygon Corp. | 1985-06-14 | 60 | 0 |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | Vygon Corp. | 1985-05-21 | 70 | 0 |
| K851474 | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | Vygon Corp. | 1985-05-07 | 22 | 0 |
| K851480 | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW | Vygon Corp. | 1985-05-07 | 22 | 0 |
| K851478 | VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183 | Vygon Corp. | 1985-05-07 | 22 | 0 |
| K851475 | VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 | Vygon Corp. | 1985-05-03 | 18 | 0 |
| K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | Vygon Corp. | 1985-05-03 | 18 | 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