FDA applicant
Philips Health Care
FDA records 20 decisions for Philips Health Care (Bothell, WA) from 2011 to 2020: 20 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 26 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 7 of them its own earlier devices. 70 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Health Care’s devices, and how often a recall has named them.
FDA decisions per year
3in 2020
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Philips Health Care’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