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

FDA lists 1,355 510(k) clearances, 85 PMA and 3 De Novo decisions across the 42 applicant names Caduvo groups under Boston Scientific, first 1976, latest 2026. Median 510(k) review time across these names: 80 days. Since 2017 the median was 84 days, against 113 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 42 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 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.

Top product codes

Plus 238 more product codes.

Review panels

• Cardiovascular (739)
• Gastroenterology and Urology (436)
• General and Plastic Surgery (86)
• Neurology (35)
• General Hospital (32)
• Obstetrics and Gynecology (30)
• Radiology (26)
• Anesthesiology (18)
• Orthopedic (17)
• Ear, Nose and Throat (15)
• Immunology (3)
• Clinical Chemistry (1)
• Physical Medicine (1)
• Clinical Toxicology (1)

Most recent Boston Scientific 510(k) clearances

1,345 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,356 product recalls in 360 recall events under these names; 367 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.

SciMed Life Systems (1995), Meadox (1996), Target Therapeutics (1997), Schneider (1998), Guidant's cardiac rhythm business incl. Cardiac Pacemakers Inc (2006), Bard Electrophysiology (2013), American Medical Systems urology (2015), EndoChoice (2016), BTG (2019), Baylis Medical (2022), Apollo Endosurgery (2023), Silk Road Medical (2024), Axonics (2024). Includes filings made before each acquisition. Left out: Target Therapeutics / BOSTON SCIENTIFIC TARGET (neurovascular business sold to Stryker 2011), GUIDANT (split between Abbott and Boston Scientific), AXONICS 1983–1985 (an unrelated earlier filer).

Sources

• https://en.wikipedia.org/wiki/Boston_Scientific
• https://en.wikipedia.org/wiki/Guidant

Frequently asked questions

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

FDA lists 1,355 510(k) clearances, 85 PMA and 3 De Novo decisions across the 42 applicant names Caduvo groups under Boston Scientific, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Boston Scientific file under?

The names with the most 510(k) clearances in this group are Boston Scientific Corp (730); Scimed Life Systems, Inc. (109); American Medical Systems, Inc. (82); Cardiac Pacemakers, Inc. (76); Meadox Medicals, Div. Boston Scientific Corp. (53). The full list of 42 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 80 days. Since 2017 the median was 84 days, against 113 days for all cleared 510(k)s in the same product codes.

Does the Boston Scientific 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 1,355 Boston Scientific clearances with predicates and recalls
• Run predicate analysis for product code DQX, Boston Scientific'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