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

FDA lists 230 510(k) clearances, 0 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Cardinal Health, first 1983, latest 2026. Median 510(k) review time across these names: 81 days. Since 2017 the median was 143 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 15 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 143 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 67 more product codes.

Review panels

• General Hospital (117)
• Gastroenterology and Urology (32)
• General and Plastic Surgery (32)
• Anesthesiology (24)
• Cardiovascular (14)
• Physical Medicine (4)
• Neurology (2)
• Orthopedic (2)
• Clinical Chemistry (1)
• Ear, Nose and Throat (1)
• Hematology (1)

Most recent Cardinal Health 510(k) clearances

220 earlier clearances. See the full list in Caduvo.

Recalls

470 product recalls in 106 recall events under these names; 183 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.

Allegiance (1999) and Medtronic's Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency businesses incl. the Kendall brand (July 2017). Kendall-named filings were made under Tyco Healthcare/Covidien before 2017. Includes filings made before each acquisition. Left out: Cardinal Health 303 / Alaris (went to CareFusion 2009, now BD), Cardinal Health 207 and Germany 234 (respiratory, now Vyaire), Cordis (owned 2015–2021).

Sources

• https://en.wikipedia.org/wiki/Cardinal_Health
• https://newsroom.cardinalhealth.com/2017-07-30-Cardinal-Health-Completes-Acquisition-of-Medtronics-Patient-Recovery-Business

Frequently asked questions

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

FDA lists 230 510(k) clearances, 0 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Cardinal Health, first 1983, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Cardinal Health file under?

The names with the most 510(k) clearances in this group are Kendall Healthcare Products Co. Div.Of Tyco Health (66); Allegiance Healthcare Corp. (64); Cardinal Health, Inc. (28); Cardinal Health200, LLC (26); Kendall (12). The full list of 15 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 81 days. Since 2017 the median was 143 days, against 147 days for all cleared 510(k)s in the same product codes.

Does the Cardinal Health 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 230 Cardinal Health clearances with predicates and recalls
• Run predicate analysis for product code KGO, Cardinal Health'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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