Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exco, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
179 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844203 | ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 | Exco, Inc. | 1985-01-02 | 64 | 0 |
| K844175 | ENTERNAL FEEDING TUBE-POLYURETHANE EF504 | Exco, Inc. | 1985-01-02 | 69 | 0 |
| K844174 | FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI | Exco, Inc. | 1984-12-07 | 43 | 0 |
| K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | Exco, Inc. | 1984-01-30 | 179 | 0 |
| K831802 | LIFE VAC #2191 & 2192 | Exco, Inc. | 1984-01-11 | 222 | 0 |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | Exco, Inc. | 1983-12-29 | 111 | 0 |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Exco, Inc. | 1983-04-05 | 15 | 0 |
| K822879 | ENTERAL NUTRITION 1 | Exco, Inc. | 1982-11-16 | 50 | 0 |
| K822836 | MICROFLEX-VENOFLUX | Exco, Inc. | 1982-10-15 | 24 | 0 |
| K822691 | VYGON EPIDURAL ANAESTHESIA TRAY | Exco, Inc. | 1982-10-15 | 42 | 0 |
| K822724 | SUCTION TUBES | Exco, Inc. | 1982-10-13 | 36 | 0 |
| K813360 | DERMAFILE (CAT. # 38 | Exco, Inc. | 1982-03-18 | 108 | 0 |
| K813374 | NUTRICATH | Exco, Inc. | 1982-03-15 | 104 | 0 |
| K820176 | VYGON ENTERNAL NUTRITION TUBES | Exco, Inc. | 1982-02-05 | 14 | 0 |
| K813373 | VYGON ENDOTRACHEAL TUBES | Exco, Inc. | 1981-12-22 | 21 | 0 |
| K813143 | DESILET | Exco, Inc. | 1981-11-27 | 22 | 0 |
| K813142 | LEADER-CATH | Exco, Inc. | 1981-11-27 | 22 | 0 |
| K813141 | VYGON STOPCOCKS & RAMPS(MANIFOLDS) | Exco, Inc. | 1981-11-27 | 22 | 0 |
| K813144 | INTRAFLON, INTRAFLUX, INTRAVALVE | Exco, Inc. | 1981-11-27 | 22 | 0 |
| K813140 | VYGON EXTENSION TUBES & CONNECTORS | Exco, Inc. | 1981-11-27 | 22 | 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