FDA applicant
Batrik Medical Manufacturing, Inc.
FDA records 1 decision for Batrik Medical Manufacturing, Inc. (Lachine, CA) in 2024: 1 510(k) clearance. All are in product code OCT (Anti Fog Solution And Accessories, Endoscopy). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Batrik Medical Manufacturing, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Batrik Medical Manufacturing, 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