Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HNC — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
18 daysmedian FDA review time
103 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022836 | STEPHENS DISPOSABLE SPECULUM | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K981235 | OCULOSTAT | Laser Center Dev. Corp. | 1998-07-15 | 103 | 0 |
| K964289 | EYE FIXATION SPECULUM | Eyefix, Inc. | 1996-12-17 | 50 | 0 |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Myocure, Inc. | 1986-09-25 | 7 | 0 |
| K843196 | VISITEC EYE SPECULUM | Visitec Co. | 1984-10-05 | 52 | 0 |
| K830430 | EYELID SPECULUM | Douglas C. Mckee & Co. | 1983-06-10 | 121 | 0 |
| K801969 | ASNIS GUIDED SCREW SYSTEMS | Howmedica Corp. | 1980-08-27 | 8 | 0 |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 | 18 | 0 |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 | 18 | 0 |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 | 18 | 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