Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQL — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | Chiron Ophthalmics | 1992-01-27 | 123 | 0 |
| K913626 | SOFTRANS INJECTOR | Staar Surgical Co. | 1991-12-18 | 125 | 0 |
| K842892 | NIDEK DIGITAL KERATOMETER | Nidek, Inc. | 1984-10-05 | 74 | 0 |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | American Medical Optics | 1984-10-01 | 97 | 0 |
| K771933 | CILCO ANTERIOR CHAMBER LENS | California Intraocular Lens | 1978-01-26 | 104 | 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