Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPJ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
75 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864012 | IRAS PERIMETER | Randwal Instrument Co., Inc. | 1986-12-12 | 58 | 0 |
| K853556 | LASER IRAS | Randwal Instrument Co., Inc. | 1985-11-01 | 67 | 0 |
| K822415 | THE OCUPLOT D | Coherent Medical Division | 1982-09-07 | 27 | 0 |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | American Laser Corp. | 1982-01-22 | 45 | 0 |
| K781507 | RETINOMETER | Coburn Optical Ind., Inc. | 1978-11-15 | 75 | 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