Philips Ultrasound, LLC: FDA filings under this applicant name

FDA lists 26 510(k) clearances under the applicant name “Philips Ultrasound, LLC” (first 2022, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 86 days, against 117 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Philips, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Philips Ultrasound, LLC took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.

Top product codes

Review panels

• Radiology (26)

Most recent Philips Ultrasound, LLC 510(k) clearances

16 earlier clearances. See the full list in Caduvo.

Recalls

3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2026-08-07.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Philips Medical Systems, Inc. (218 510(k)s)
• Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
• Philips Medical Systems Nederland B.V. (106 510(k)s)
• Philips Medical Systems North America, Inc. (95 510(k)s)
• Philips Ultrasound, Inc. (51 510(k)s)
• Philips Medizin Systeme Boeblingen GmbH (48 510(k)s)
• Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
• Philips Medizin Systeme Boblingen GmbH (22 510(k)s)
• Philips Health Care (20 510(k)s)
• Philips Hearing Instruments Co. (20 510(k)s)
• Philips Medical Systems Dmc GmbH (18 510(k)s)
• Philips Healthcare (Suzhou) Co., Ltd. (17 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Philips Ultrasound, LLC?

FDA lists 26 510(k) clearances under the applicant name “Philips Ultrasound, LLC” (first 2022, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Philips Ultrasound, LLC?

The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Ultrasound, LLC is 86 days. Since 2017: 86 days, versus 117 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Philips Ultrasound, LLC?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 24); JAK (System, X-Ray, Tomography, Computed, 1); QIH (Automated Radiological Image Processing Software, 1).

Next steps

• See all 26 Philips Ultrasound, LLC clearances with predicates and recalls
• Run predicate analysis for product code IYN, Philips Ultrasound, LLC's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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