FDA applicant
Congruence Medical Solutions, LLC
FDA records 1 decision for Congruence Medical Solutions, LLC (Baltimore, MD) in 2024: 1 510(k) clearance. All are in product code QLY (Ophthalmic Syringe). Its devices cite 1 predicate, 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 Congruence Medical Solutions, LLC’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 Congruence Medical Solutions, LLC’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