FDA applicant
Philips Ultrasound, Inc.
FDA records 78 decisions for Philips Ultrasound, Inc. (Bothell, WA) from 1985 to 2026: 78 510(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 72 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 111 predicates, 59 of them its own earlier devices. 132 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Philips Ultrasound, LLC”, “Philips Ultrasound”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Ultrasound, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
12in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Philips Ultrasound, 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