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

FDA lists 1,717 510(k) clearances, 119 PMA and 5 De Novo decisions across the 68 applicant names Caduvo groups under Abbott, first 1976, latest 2026. Median 510(k) review time across these names: 70 days. Since 2017 the median was 112 days, against 134 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 68 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 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.

Top product codes

Plus 443 more product codes.

Review panels

• Cardiovascular (611)
• Clinical Chemistry (495)
• General Hospital (163)
• Clinical Toxicology (159)
• Microbiology (158)
• Hematology (80)
• Gastroenterology and Urology (56)
• Immunology (50)
• General and Plastic Surgery (17)
• Neurology (16)
• Anesthesiology (15)
• Pathology (8)
• Radiology (3)
• Medical Genetics (1)
• Obstetrics and Gynecology (1)

Most recent Abbott 510(k) clearances

1,707 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

868 product recalls in 449 recall events under these names; 178 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.

St. Jude Medical (January 2017; brought Pacesetter, AGA Medical, Thoratec), Alere (October 2017; brought Biosite and Inverness Medical), Advanced Cardiovascular Systems (Guidant vascular, 2006), i-STAT (2004), TheraSense (2004), MediSense (1996), Evalve (2009), Cardiovascular Systems Inc (2023). Includes filings made before each acquisition. Left out: Abbott Medical Optics (sold to Johnson & Johnson 2017), ALERE (a 1984 filer predating Alere Inc), AGA MEDICAL PRODUCTS (1992–1993, predates AGA Medical), Abbott Spine (sold to Zimmer 2008), AbbVie (pharma spin-off 2013). The generic CARDIOVASCULAR SYSTEMS names are left out because not every filing could be confirmed as the company acquired in 2023.

Sources

• https://en.wikipedia.org/wiki/Abbott_Laboratories
• https://en.wikipedia.org/wiki/St._Jude_Medical
• https://en.wikipedia.org/wiki/Alere
• https://en.wikipedia.org/wiki/Thoratec

Frequently asked questions

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

FDA lists 1,717 510(k) clearances, 119 PMA and 5 De Novo decisions across the 68 applicant names Caduvo groups under Abbott, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Abbott file under?

The names with the most 510(k) clearances in this group are Abbott Laboratories (889); St Jude Medical (128); Advanced Cardiovascular Systems, Inc. (103); Pacesetter Systems (96); ABBOTT MEDICAL (60). The full list of 68 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 70 days. Since 2017 the median was 112 days, against 134 days for all cleared 510(k)s in the same product codes.

Does the Abbott 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 1,717 Abbott clearances with predicates and recalls
• Run predicate analysis for product code FRN, Abbott'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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