Serpex Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Serpex Medical, Inc.” (first 2022, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 130 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 |
|---|---|---|
| 2022 | 2 | 112 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 28 |
| 2026 | 2 | 69 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Serpex Medical, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 2 | 2 |
| KTI | Bronchoscope Accessory | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent Serpex Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | GEH | 2026-09-02 | 48 |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | GEH | 2026-06-30 | 90 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | KTI | 2025-10-08 | 28 |
| K221206 | Compass Steerable Needle | KTI | 2022-08-25 | 121 |
| K221302 | Recon Steerable Sheath | EOQ | 2022-08-15 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Serpex Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Serpex Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Serpex Medical, Inc.” (first 2022, latest 2026), 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 Serpex Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Serpex Medical, Inc. is 90 days. Since 2017: 90 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Serpex Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 2); KTI (Bronchoscope Accessory, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 5 Serpex Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Serpex Medical, 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.