Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQJ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Acces Intl. Eyewear | 1989-12-18 | 42 | 0 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | 40 | 0 |
| K875014 | LABTICIAN RETINAL IMPLANTS | Labtician Products, Inc. | 1988-02-26 | 84 | 0 |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Bcd Products, Inc. | 1983-08-16 | 75 | 0 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 | 36 | 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