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

FDA lists 456 510(k) clearances, 3 PMA and 0 De Novo decisions across the 11 applicant names Caduvo groups under KARL STORZ, first 1980, latest 2026. Median 510(k) review time across these names: 89 days. Since 2017 the median was 153 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 11 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 153 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 82 more product codes.

Review panels

• Gastroenterology and Urology (127)
• General and Plastic Surgery (102)
• Obstetrics and Gynecology (82)
• Ear, Nose and Throat (71)
• Orthopedic (42)
• Neurology (14)
• Radiology (6)
• General Hospital (5)
• Cardiovascular (4)
• Anesthesiology (3)
• Ophthalmic (2)
• Dental (1)

Most recent KARL STORZ 510(k) clearances

446 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

91 product recalls in 34 recall events under these names; 52 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.

KARL STORZ is privately held; all names are KARL STORZ entities. Not related to Storz Instrument Co (Bausch + Lomb).

Sources

• https://en.wikipedia.org/wiki/Karl_Storz_SE

Frequently asked questions

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

FDA lists 456 510(k) clearances, 3 PMA and 0 De Novo decisions across the 11 applicant names Caduvo groups under KARL STORZ, first 1980, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does KARL STORZ file under?

The names with the most 510(k) clearances in this group are KARL STORZ Endoscopy-America, Inc. (334); Karl Storz Endoscopy (35); Karl Storz Endoscopy America, Inc. (30); Karl Storz SE & CO. KG (30); Karl Storz Endoskop GmbH (11). The full list of 11 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 89 days. Since 2017 the median was 153 days, against 113 days for all cleared 510(k)s in the same product codes.

Does the KARL STORZ 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 456 KARL STORZ clearances with predicates and recalls
• Run predicate analysis for product code GCJ, KARL STORZ'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