Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Welcon, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
181 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0 | Welcon, Inc. | 2001-05-01 | 181 | 0 |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVI | Welcon, Inc. | 1998-02-05 | 128 | 0 |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | 1997-07-29 | 77 | 0 |
| K912869 | WOMEN AND INFANT'S DELIVERY PACK | Welcon, Inc. | 1991-12-04 | 159 | 0 |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Welcon, Inc. | 1990-11-29 | 83 | 0 |
| K894397 | WELCON LIGHT HANDLE | Welcon, Inc. | 1989-08-10 | 21 | 0 |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | Welcon, Inc. | 1983-03-17 | 42 | 16 |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | Welcon, Inc. | 1981-11-20 | 23 | 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