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

FDA lists 821 510(k) clearances, 5 PMA and 1 De Novo decisions across the 23 applicant names Caduvo groups under Baxter, first 1977, latest 2026. Median 510(k) review time across these names: 86 days. Since 2017 the median was 134 days, against 147 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 23 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 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.

Top product codes

Plus 264 more product codes.

Review panels

• General Hospital (252)
• Cardiovascular (169)
• Gastroenterology and Urology (118)
• Clinical Chemistry (53)
• General and Plastic Surgery (38)
• Anesthesiology (37)
• Obstetrics and Gynecology (28)
• Microbiology (18)
• Orthopedic (18)
• Physical Medicine (18)
• Hematology (16)
• Ophthalmic (15)
• Ear, Nose and Throat (14)
• Clinical Toxicology (7)
• Neurology (6)
• Dental (5)
• Pathology (3)
• Radiology (3)
• Immunology (1)

Most recent Baxter 510(k) clearances

811 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

913 product recalls in 416 recall events under these names; 280 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.

Hill-Rom (December 2021; incl. Welch Allyn 2015, Mortara 2017, Bardy Diagnostics 2021) and Synovis (2012). Includes filings made before each acquisition. Left out: Kidney Care (Gambro, renal division) — sold to Carlyle as Vantive on January 31, 2025; the main BAXTER HEALTHCARE name still contains pre-2025 renal filings that cannot be split out. Also left out: Baxter Diagnostics (became Dade, now Siemens Healthineers), Baxter Edwards (now Edwards Lifesciences), BioScience (Baxalta/Takeda), Travenol-era names (mixed businesses later divested).

Sources

• https://en.wikipedia.org/wiki/Baxter_International
• https://en.wikipedia.org/wiki/Hill-Rom
• https://en.wikipedia.org/wiki/Welch_Allyn
• https://www.sec.gov/Archives/edgar/data/10456/000162828025004275/bax-2025013125xex991.htm

Frequently asked questions

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

FDA lists 821 510(k) clearances, 5 PMA and 1 De Novo decisions across the 23 applicant names Caduvo groups under Baxter, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Baxter file under?

The names with the most 510(k) clearances in this group are Baxter Healthcare Corp (568); Welch Allyn, Inc. (112); Mortara Instrument, Inc. (51); Hill-Rom, Inc. (37); Synovis Life Technologies, Inc. (9). The full list of 23 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 86 days. Since 2017 the median was 134 days, against 147 days for all cleared 510(k)s in the same product codes.

Does the Baxter 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 821 Baxter clearances with predicates and recalls
• Run predicate analysis for product code FPA, Baxter'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.

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