Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Key Surgical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
204 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | 2015-09-22 | 204 | 0 |
| K151222 | Cautery Tip Cleaner | Key Surgical, Inc. | 2015-05-22 | 15 | 0 |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 | 40 | 0 |
| K896676 | KEY VASCULAR LOOPS | Key Surgical, Inc. | 1990-02-27 | 92 | 0 |
| K896472 | KEY VASCULAR BOOTIES | Key Surgical, Inc. | 1989-12-14 | 31 | 0 |
| K895591 | SILICONE INSTRUMENT SHODS | Key Surgical, Inc. | 1989-10-20 | 35 | 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