Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PCF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
170 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF | Femasys, Inc. | 2012-12-20 | 111 | 0 |
| K060320 | FEMECC ENDOCERVICAL CURETTE | Femspec LLC | 2006-07-28 | 170 | 0 |
| K882606 | EURO-MED ENDO-CURETTE | Buckman Co., Inc. | 1988-07-25 | 31 | 0 |
| K882404 | KEVOR-CURETTE | Euro-Med Intl. | 1988-07-08 | 28 | 0 |
| K860796 | DISPO-URETTE | Roland J. Zwick, Inc. | 1986-04-08 | 35 | 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