Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Femspec LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060320 | FEMECC ENDOCERVICAL CURETTE | Femspec LLC | 2006-07-28 | 170 | 0 |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | 2006-02-02 | 175 | 0 |
| K051294 | FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 | Femspec LLC | 2005-12-21 | 217 | 0 |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Femspec LLC | 2004-12-23 | 177 | 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