Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852548 | ATL 225 MW TRAIL LENS SET | Ascon Medical Instruments, Ltd. | 1985-07-31 | 49 | 0 |
| K852126 | ATF 101 TRAIL FRAME | Ascon Medical Instruments, Ltd. | 1985-06-05 | 21 | 0 |
| K841768 | WOODLYN LIGHTWEIGHT TRIAL FRAME | Woodlyn, Inc. | 1984-06-01 | 35 | 0 |
| K833669 | IMAGE DEFLECTOR | Michael Onufryk | 1984-03-27 | 161 | 0 |
| K821084 | UNIVERSAL TRIAL FRAMEE | Medical Equipment Designs, Inc. | 1982-06-14 | 56 | 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