FDA applicant
Serpex Medical, Inc.
FDA records 5 decisions for Serpex Medical, Inc. (Santa Clara, CA) from 2022 to 2026: 5 510(k) clearances. Most are in product codes KTI (Bronchoscope Accessory) and GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Serpex Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Serpex Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Serpex Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report