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

FDA lists 281 510(k) clearances, 24 PMA and 3 De Novo decisions across the 22 applicant names Caduvo groups under Hologic, first 1984, latest 2026. Median 510(k) review time across these names: 90 days. Since 2017 the median was 112 days, against 110 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 22 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 110 days.

Top product codes

Plus 77 more product codes.

Review panels

• Radiology (115)
• Microbiology (107)
• General and Plastic Surgery (32)
• Obstetrics and Gynecology (31)
• Clinical Chemistry (8)
• Pathology (7)
• General Hospital (3)
• Hematology (2)
• Immunology (1)
• Clinical Toxicology (1)

Most recent Hologic 510(k) clearances

271 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

77 product recalls in 60 recall events under these names; 25 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.

Lorad (2000), R2 Technology (2006), Suros (2007), Cytyc (2007), Third Wave (2008), Gen-Probe (2012), Faxitron (2021), Gynesonics (2024). Includes filings made before each acquisition. Left out: Cynosure (owned 2017–2020, then sold).

Sources

• https://en.wikipedia.org/wiki/Hologic
• https://en.wikipedia.org/wiki/Gen-Probe

Frequently asked questions

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

FDA lists 281 510(k) clearances, 24 PMA and 3 De Novo decisions across the 22 applicant names Caduvo groups under Hologic, first 1984, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Hologic file under?

The names with the most 510(k) clearances in this group are Hologic, Inc. (118); Gen-Probe, Inc. (62); Lorad Corp. (12); Gen-Probe Prodesse, Inc. (10); Gynesonics, Inc. (8). The full list of 22 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 90 days. Since 2017 the median was 112 days, against 110 days for all cleared 510(k)s in the same product codes.

Does the Hologic 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 281 Hologic clearances with predicates and recalls
• Run predicate analysis for product code KGI, Hologic'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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