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

FDA lists 224 510(k) clearances, 0 PMA and 0 De Novo decisions across the 3 applicant names Caduvo groups under Intuitive Surgical, first 1993, latest 2026. Median 510(k) review time across these names: 96 days. Since 2017 the median was 90 days, against 124 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 3 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 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.

Top product codes

Plus 5 more product codes.

Review panels

• General and Plastic Surgery (199)
• Ear, Nose and Throat (11)
• General Hospital (8)
• Radiology (3)
• Obstetrics and Gynecology (2)
• Gastroenterology and Urology (1)

Most recent Intuitive Surgical 510(k) clearances

214 earlier clearances. See the full list in Caduvo.

Recalls

277 product recalls in 122 recall events under these names; 72 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.

Intuitive Surgical merged with Computer Motion in 2003. Includes Computer Motion's filings made before the merger.

Sources

• https://en.wikipedia.org/wiki/Intuitive_Surgical
• https://en.wikipedia.org/wiki/Computer_Motion

Frequently asked questions

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

FDA lists 224 510(k) clearances, 0 PMA and 0 De Novo decisions across the 3 applicant names Caduvo groups under Intuitive Surgical, first 1993, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Intuitive Surgical file under?

The names with the most 510(k) clearances in this group are Intuitive Surgical, Inc. (197); Computer Motion, Inc. (26); Intuitive Surgical Operations, Inc. (1). The full list of 3 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 96 days. Since 2017 the median was 90 days, against 124 days for all cleared 510(k)s in the same product codes.

Does the Intuitive Surgical 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 224 Intuitive Surgical clearances with predicates and recalls
• Run predicate analysis for product code NAY, Intuitive Surgical'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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