Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EHB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921355 | WINGMASTER | Innovators, Inc. | 1992-09-25 | 189 | 0 |
| K903012 | AUDIOPRAT ENDOSCOPE | S.C.D.P.I. of Florida, Inc. | 1990-10-09 | 90 | 0 |
| K834606 | X-RAY COLLIMATOR X-CJD | Knochen Dental Laboratory | 1984-02-21 | 55 | 0 |
| K833558 | X-RAY SHIELD | Moyco Industries, Inc. | 1984-01-13 | 92 | 0 |
| K781675 | X-RAY COLLIMATOR | General X-Ray, Inc. | 1978-12-04 | 66 | 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