FDA applicant
Thermo Fisher Scientific
FDA records 65 decisions for Thermo Fisher Scientific (Oakwood Village, OH) from 2007 to 2025: 65 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and NGZ (Susceptibility Test Plate, Antifungal). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Thermo Fisher Scientific, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Thermo Fisher Scientific’s devices, and how often a recall has named them.
FDA decisions per year
10in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Thermo Fisher Scientific’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) ReportOther applicant names beginning “Thermo”
FDA records each applicant name separately; these may or may not be the same firm.