Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Femasys, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
193 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025-12-15 | 76 | 0 |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024-11-22 | 136 | 0 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024-09-06 | 86 | 0 |
| K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | 2023-09-22 | 101 | 0 |
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF | Femasys, Inc. | 2012-12-20 | 111 | 0 |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | Femasys, Inc. | 2011-10-12 | 187 | 0 |
| K110288 | FEMVUE SALINE-AIR DEVICE | Femasys, Inc. | 2011-04-28 | 86 | 0 |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | Femasys, Inc. | 2010-04-07 | 30 | 0 |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | Femasys, Inc. | 2009-06-23 | 193 | 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