Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HFE — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
163 daysmedian FDA review time
1170 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | 2024-08-14 | 163 | 0 |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017-05-24 | 84 | 0 |
| K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER | Post Oak Innovations, Inc. | 2012-06-18 | 270 | 0 |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | 2008-11-07 | 108 | 1 |
| K941298 | IUMC ENDOMETRIAL SAMPLER | Cook Ob/Gyn | 1995-02-13 | 333 | 1 |
| K911620 | STOVALL ENDOMETRIAL BRUSH | Cook Ob/Gyn | 1994-06-24 | 1170 | 0 |
| K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Intl. Cytobrush, Inc. | 1990-09-10 | 262 | 0 |
| K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Laboratoire Ccd C/O Washington Regulatory Services | 1988-06-14 | 84 | 0 |
| K843941 | ENDOCYTE | Gyneco, Inc. | 1985-02-25 | 139 | 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