FDA applicant
Siemens Healthcare Diagnostics, Inc.
FDA records 265 decisions for Siemens Healthcare Diagnostics, Inc. (Tarrytown, NY) from 1995 to 2026: 245 510(k) clearances, 1 De Novo grant and 19 original PMA approvals. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JIX (Calibrator, Multi-Analyte Mixture). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 340 predicates, 84 of them its own earlier devices. 247 recalls are linked to its devices.
FDA’s records also spell it “Siemens Healthcare Diagnostics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Healthcare Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
7in 2026
Class I Class II/III not classified
Planning a device like Siemens Healthcare Diagnostics, 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