510(k) Report

FDA applicant

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT2 decisions1985–19860 recalls

FDA records 2 decisions for Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT) from 1985 to 1986: 2 510(k) clearances. Most are in product codes BYP (Mouthpiece, Breathing) and GAX (Tourniquet, Nonpneumatic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Boehringer Ingelheim Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boehringer Ingelheim Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boehringer Ingelheim Pharmaceuticals, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BYPMouthpiece, Breathing1decision
  • GAXTourniquet, Nonpneumatic1decision

What has FDA decided for it lately?

  • K863049Inhalation AidBoehringer Ingelheim Pharmaceuticals, Inc. · 1986
  • K852277Catapress TourniguetBoehringer Ingelheim Pharmaceuticals, Inc. · 1985

All 2 as Boehringer Ingelheim Pharmaceuticals, Inc. →

Other applicant names beginning “Boehringer”

FDA records each applicant name separately; these may or may not be the same firm.

Boehringer Mannheim Corp. 341Boehringer Laboratories 44Boehringer Mannheim Italia Spa 3Boehringer/Miter, Inc. 1