# Boehringer Laboratories

- Location (FDA's records): Norristown, PA
- FDA decisions: 44 (1976–2026): 44 510(k) clearances
- Names in FDA's records: Boehringer Laboratories (38); Boehringer Laboratories, LLC (6)
- Product codes: CAC (12), KDP (4), KNT (4), GCJ (3), BZK (3), GCX (2), KDQ (2), GFA (2), CBP (1), BYE (1), JOH (1), CFJ (1)
- 510(k) review time since 2016: median 104 days, against 104 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 16 (6 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Applied Medical Resources: 2 (https://510kreport.com/company/applied-medical-resources)
- Blue Sky Medical Group Incorporated: 2 (https://510kreport.com/company/blue-sky-medical-group)
- Livac Pty, Ltd.: 1 (https://510kreport.com/company/livac)
- Obtech Medical GmbH: 1 (https://510kreport.com/company/obtech-medical)
- Crospon, Ltd.: 1 (https://510kreport.com/company/crospon)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Firms that cite its devices most
- Incappe, Inc.: 1 (https://510kreport.com/company/incappe)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Tools For Surgery, LLC: 1 (https://510kreport.com/company/tools-for-surgery)
- Naser Dib Gabinet Lekarksi Nasmed: 1 (https://510kreport.com/company/naser-dib-gabinet-lekarksi-nasmed)
- Medical Innovation Development: 1 (https://510kreport.com/company/medical-innovation-development)
- Hospitech Respiration, Ltd.: 1 (https://510kreport.com/company/hospitech-respiration)
- Standard Bariatrics: 1 (https://510kreport.com/company/standard-bariatrics)
- Iasis Medical, Inc.: 1 (https://510kreport.com/company/iasis-medical)

## Its most-cited devices
- K130483: Boehringer Gastric Sizing Tube (2013), cited by 8
- K060277: Boehringer Laboratories Suction Pump System (2006), cited by 3
- K150781: Tissue Removal Pouch (2015), cited by 1
- K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (2024), cited by 1
- K020538: Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series (2002), cited by 1
- K061788: Boehringer Laboratories Suction Pump System (2006), cited by 1

## Recent decisions
- K261890: 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® (Aug 14, 2026)
- K243399: Boehringer Laboratories Liver Retractor (Jul 2, 2025)
- K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)
- K234145: ViSiGi 3D Gastric Sizing Tube (Jan 26, 2024)
- K151990: Tissue Removal System (Sep 11, 2015)
- K150781: Tissue Removal Pouch (Jun 19, 2015)
- K130483: Boehringer Gastric Sizing Tube (Mar 28, 2013)
- K061788: Boehringer Laboratories Suction Pump System (Jul 11, 2006)

Source page: https://510kreport.com/company/boehringer-laboratories