Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HFF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
226 daysmedian FDA review time
428 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041237 | ECHOSAMPLER | Gynetics Medical Products NV | 2004-09-08 | 120 | 0 |
| K903002 | PROBET (TM) | Gynopharma, Inc. | 1991-04-05 | 270 | 0 |
| K902693 | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER | Wallach Surgical Devices, Inc. | 1991-01-31 | 226 | 0 |
| K831212 | ENDOSCANN | Axcan Scientific Corp. | 1984-06-15 | 428 | 0 |
| K820641 | ACCURETTE | Axcan Scientific Corp. | 1982-06-22 | 106 | 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