Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stephens Instruments — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
66 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022842 | STEPHENS DISPOSABLE HOOKS | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K022836 | STEPHENS DISPOSABLE SPECULUM | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K022840 | STEPHENS DISPOSABLE SCISSORS | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K022835 | STEPHENS DISPOSABLE FORCEPS | Stephens Instruments | 2002-11-01 | 66 | 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