510(k) Report

FDA applicant

Boehringer Laboratories

Norristown, PA44 decisions1976–20269 recalls

FDA records 44 decisions for Boehringer Laboratories (Norristown, PA) from 1976 to 2026: 44 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and KDP (Regulator, Vacuum). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Boehringer Laboratories, LLC”.

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 Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12015: 22024: 22025: 12026 (partial year): 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2009: 42010: 1
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Boehringer Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CACApparatus, Autotransfusion12decisions
  • KDPRegulator, Vacuum4decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • BZKSpirometer, Monitoring (W/Wo Alarm)3decisions
  • GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2decisions

Also: KDQ (2), GFA (2), CBP (1), BYE (1), JOH (1), CFJ (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 20138cite it
  • K060277Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 20063cite it
  • K150781Tissue Removal PouchBoehringer Laboratories, LLC · 20151cites it
  • K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 20241cites it
  • K020538Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesBoehringer Laboratories · 20021cites it
  • K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 20061cites it

What has FDA decided for it lately?

  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K243399Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025
  • K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 2024
  • K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024
  • K151990Tissue Removal SystemBoehringer Laboratories, LLC · 2015
  • K150781Tissue Removal PouchBoehringer Laboratories, LLC · 2015
  • K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
  • K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 20065 recalls

All 38 as Boehringer Laboratories →All 6 as Boehringer Laboratories, LLC →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K061788Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound TherapyJul 9, 2010
  • K061788Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System…Jul 29, 2009
  • K061788Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy…Jul 29, 2009
  • K061788Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative…Jul 29, 2009
  • K061788ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy…Jul 13, 2009
  • K853095Boehringer Suction Regulator Model number 3704D3Aug 1, 2005

Other applicant names beginning “Boehringer”

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

Boehringer Mannheim Corp. 341Boehringer Mannheim Italia Spa 3Boehringer Ingelheim Pharmaceuticals, Inc. 2Boehringer/Miter, Inc. 1