Boehringer Laboratories: FDA filings under this applicant name

FDA lists 44 510(k) clearances under the applicant name “Boehringer Laboratories” (first 1976, latest 2026), across 20 product codes in 6 review panels. Median 510(k) review time under this name: 83 days. Since 2017 the median was 104 days, against 154 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Boehringer Laboratories took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.

Top product codes

Plus 10 more product codes.

Review panels

• Cardiovascular (12)
• Anesthesiology (9)
• General Hospital (9)
• General and Plastic Surgery (8)
• Gastroenterology and Urology (4)
• Clinical Chemistry (2)

Most recent Boehringer Laboratories 510(k) clearances

34 earlier clearances. See the full list in Caduvo.

Recalls

6 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2005-08-01.

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Boehringer Laboratories (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via CAF)

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.

• Boehringer Mannheim Corp. (340 510(k)s)
• Boehringer Mannheim Italia Spa (3 510(k)s)
• Boehringer Ingelheim Pharmaceuticals, Inc. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Boehringer Laboratories?

FDA lists 44 510(k) clearances under the applicant name “Boehringer Laboratories” (first 1976, latest 2026), across 20 product codes in 6 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 Boehringer Laboratories?

The median time from FDA receipt to decision across 510(k)s cleared under the name Boehringer Laboratories is 83 days. Since 2017: 104 days, versus 154 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Boehringer Laboratories?

The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 12); KDP (Regulator, Vacuum, 4); KNT (Tubes, Gastrointestinal (And Accessories), 4).

Next steps

• See all 44 Boehringer Laboratories clearances with predicates and recalls
• Run predicate analysis for product code CAC, Boehringer Laboratories'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, with punctuation and legal suffixes removed; 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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