Philips: FDA 510(k) clearances across all its applicant names

FDA lists 1,756 510(k) clearances, 13 PMA and 2 De Novo decisions across the 86 applicant names Caduvo groups under Philips, first 1976, latest 2026. Median 510(k) review time across these names: 78 days. Since 2017 the median was 92 days, against 132 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 86 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.

Top product codes

Plus 190 more product codes.

Review panels

• Radiology (845)
• Cardiovascular (507)
• Anesthesiology (266)
• Obstetrics and Gynecology (45)
• Neurology (23)
• General and Plastic Surgery (15)
• Clinical Toxicology (11)
• Pathology (9)
• Gastroenterology and Urology (8)
• General Hospital (7)
• Clinical Chemistry (4)
• Dental (4)
• Ear, Nose and Throat (4)
• Physical Medicine (4)

Most recent Philips 510(k) clearances

1,746 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2,048 product recalls in 794 recall events under these names; 834 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

ATL Ultrasound (1998), ADAC Laboratories (2000), Hewlett-Packard/Agilent's medical business (2001; the HEWLETT-PACKARD names are HP's 1976–2000 medical filings), Marconi Medical/Picker (2001), Invivo (2004), Respironics (2008), Volcano (2015), Spectranetics (2017), BioTelemetry (2021). Includes filings made before each acquisition. Left out: lighting, consumer electronics and hearing-instrument names (divested), Lifeline Systems (acquired 2006, sold 2021), Agilent (kept life-science and diagnostics businesses after 2001).

Sources

• https://en.wikipedia.org/wiki/Philips_Healthcare
• https://en.wikipedia.org/wiki/Respironics
• https://en.wikipedia.org/wiki/Agilent_Technologies

Frequently asked questions

How many FDA 510(k) clearances are listed across Philips's applicant names?

FDA lists 1,756 510(k) clearances, 13 PMA and 2 De Novo decisions across the 86 applicant names Caduvo groups under Philips, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Philips file under?

The names with the most 510(k) clearances in this group are Hewlett-Packard Co. (246); Philips Medical Systems, Inc. (218); Philips Medical Systems (Cleveland), Inc. (190); Respironics, Inc. (173); Philips Medical Systems Nederland B.V. (106). The full list of 86 names is on this page.

How long does FDA take to clear Philips 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 78 days. Since 2017 the median was 92 days, against 132 days for all cleared 510(k)s in the same product codes.

Does the Philips count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 1,756 Philips clearances with predicates and recalls
• Run predicate analysis for product code LNH, Philips's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

All parent companies · FDA device companies by applicant name · FDA product code lookup