Femasys, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Femasys, Inc.” (first 2009, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 94 days, against 196 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 111 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 101 |
| 2024 | 2 | 111 |
| 2025 | 1 | 76 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Femasys, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 7 | 7 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
| PCF | Sampler, Endocervical | 1 | 1 |
Review panels
Most recent Femasys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | LKF | 2025-12-15 | 76 |
| K242002 | FemVue MINI Saline-Air Device | LKF | 2024-11-22 | 136 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | LKF | 2024-09-06 | 86 |
| K231730 | FemaSeed Intratubal Insemination | MQF | 2023-09-22 | 101 |
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | PCF | 2012-12-20 | 111 |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | LKF | 2011-10-12 | 187 |
| K110288 | FEMVUE SALINE-AIR DEVICE | LKF | 2011-04-28 | 86 |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | LKF | 2010-04-07 | 30 |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | LKF | 2009-06-23 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Femasys, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Femasys, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05977751: Prospective Multi-Center Trial for FemBloc Permanent Birth Control (Recruiting, started 2023-10-31)
- NCT04968847: FemaSeed LOCAL Artificial Insemination Trial (Completed, started 2021-07-15)
- NCT04273594: FemBloc® Permanent Contraception - Confirmation Feasibility Trial (Active not recruiting, started 2020-02-27)
- NCT03433911: FemBloc® Permanent Contraception - Early Pivotal Trial (Completed, started 2018-02-02)
- NCT03067272: Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (Completed, started 2017-03-15)
SEC filings
FEMASYS INC (FEMY): EDGAR filings, CIK 1339005. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Femasys, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Femasys, Inc.” (first 2009, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Femasys, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Femasys, Inc. is 101 days. Since 2017: 94 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Femasys, Inc.?
The most frequent FDA product codes under this applicant name are LKF (Cannula, Manipulator/Injector, Uterine, 7); MQF (Catheter, Assisted Reproduction, 1); PCF (Sampler, Endocervical, 1).
Next steps
- See all 9 Femasys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKF, Femasys, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.