FDA applicant
First Source, Inc.
FDA records 3 decisions for First Source, Inc. (Rochester, NY) from 2021 to 2024: 3 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided First Source, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like First Source, 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