Karl Storz SE & CO. KG: FDA filings under this applicant name

FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Karl Storz SE & CO. KG” (first 2018, latest 2026), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 168 days. Since 2017 the median was 168 days, against 106 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under KARL STORZ, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Karl Storz SE & CO. KG took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.

Top product codes

Plus 8 more product codes.

Review panels

• Gastroenterology and Urology (11)
• General and Plastic Surgery (8)
• Obstetrics and Gynecology (6)
• Ear, Nose and Throat (4)
• Orthopedic (1)

Most recent Karl Storz SE & CO. KG 510(k) clearances

20 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Karl Storz SE & CO. KG.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Karl Storz SE & CO. KG (29)
• KARL STORZ SE & CO. KG (1)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• KARL STORZ Endoscopy-America, Inc. (367 510(k)s)
• Karl Storz Endoscopy (35 510(k)s)
• Karl Storz Endoskop GmbH (11 510(k)s)
• Karl Storz Imaging, Inc. (10 510(k)s)
• Karl Leibinger GmbH U. Co. KG (1 510(k)s)
• Karl M. Block Co. (1 510(k)s)
• Karl Storz Endovision, Inc. (1 510(k)s)
• Karl Storz GmbH & Co. (Kst) (1 510(k)s)
• Karl Storz Lithotripsy-America, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Karl Storz SE & CO. KG?

FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Karl Storz SE & CO. KG” (first 2018, latest 2026), across 18 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Karl Storz SE & CO. KG?

The median time from FDA receipt to decision across 510(k)s cleared under the name Karl Storz SE & CO. KG is 168 days. Since 2017: 168 days, versus 106 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Karl Storz SE & CO. KG?

The most frequent FDA product codes under this applicant name are FGB (Ureteroscope And Accessories, Flexible/Rigid, 4); OWN (Confocal Optical Imaging, 4); GCJ (Laparoscope, General & Plastic Surgery, 3).

Next steps

• See all 30 Karl Storz SE & CO. KG clearances with predicates and recalls
• Run predicate analysis for product code FGB, Karl Storz SE & CO. KG's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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