FDA applicant
Centerline Biomedical, Inc.
FDA records 8 decisions for Centerline Biomedical, Inc. (Cleveland, OH) from 2019 to 2026: 8 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 11 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
FDA’s records also spell it “Centerline Biomedical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Centerline Biomedical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Centerline Biomedical, 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