Femcare , Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Femcare , Ltd.” (first 1988, latest 1994), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 157 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNH | Laparoscopic Contraceptive Tubal Occlusion Device | 1 | 0 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
Review panels
Most recent Femcare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932465 | LI VASECTOMY | KOA | 1994-03-02 | 285 |
| K884061 | ADD-A-CATH | KOB | 1988-10-25 | 29 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P920046 | PMA | FILSHIE CLIP (MARK VI) SYSTEM | 1996-09-05 |
Recalls
openFDA lists no recalls under a recalling firm named Femcare , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Femcare , Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Femcare , Ltd.” (first 1988, latest 1994), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Femcare , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Femcare , Ltd. is 157 days.
Which FDA product codes appear under Femcare , Ltd.?
The most frequent FDA product codes under this applicant name are KNH (Laparoscopic Contraceptive Tubal Occlusion Device, 1); KOA (Surgical Instruments, G-U, Manual (And Accessories), 1); KOB (Catheter, Suprapubic (And Accessories), 1).
Next steps
- See all 2 Femcare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNH, Femcare , Ltd.'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.