Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitaid, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
267 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND | Vitaid, Ltd. | 2005-06-30 | 92 | 3 |
| K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE | Vitaid, Ltd. | 1993-11-02 | 153 | 0 |
| K901738 | SELFCATH | Vitaid, Ltd. | 1990-06-27 | 71 | 0 |
| K894883 | PHYCON ALL SILICONE BALLOON CATHETER | Vitaid, Ltd. | 1990-04-25 | 267 | 0 |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | 1989-11-21 | 116 | 0 |
| K894669 | LASER SHIELDING TUBE | Vitaid, Ltd. | 1989-10-13 | 81 | 0 |
| K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Vitaid, Ltd. | 1989-09-29 | 77 | 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