Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Knight Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
300 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921127 | PANDA NEEDLE CATHETER JEJUNOSTOMY KIT | Knight Medical, Inc. | 1993-01-04 | 300 | 0 |
| K903086 | TUBE GASTROSTOMY | Knight Medical, Inc. | 1990-11-20 | 131 | 0 |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | 1989-03-02 | 171 | 0 |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Knight Medical, Inc. | 1988-12-19 | 97 | 0 |
| K862489 | ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE | Knight Medical, Inc. | 1986-09-23 | 85 | 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