FDA applicant
Philips Medical Systems, Inc.
FDA records 225 decisions for Philips Medical Systems, Inc. (Andover, MA) from 1983 to 2026: 221 510(k) clearances and 4 original PMA approvals. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and MKJ (Automated External Defibrillators (Non-Wearable)). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 379 predicates, 150 of them its own earlier devices. 452 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Philips Medical Systems”, “Philips Medical Systems B.V.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Philips Medical Systems, 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