# Lexion Medical, LLC

- Location (FDA's records): St. Paul, MN
- FDA decisions: 13 (2007–2019): 13 510(k) clearances
- Product codes: HIF (12), FCX (1)
- Predicates its devices cite: 31 (16 its own); citations of its devices by later devices: 17 (16 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 3 (https://510kreport.com/company/ethicon-endo-surgery)
- Surgiquest, Inc.: 3 (https://510kreport.com/company/surgiquest)
- W.O.M. World of Medicine GmbH: 3 (https://510kreport.com/company/wom-world-of-medicine)
- Cardia Innovation AB: 2 (https://510kreport.com/company/cardia-innovation)
- E-Z-Em, Inc.: 2 (https://510kreport.com/company/e-z-em)
- Cardiothoracic Systems, Inc.: 1 (https://510kreport.com/company/cardiothoracic-systems)
- Georgia Biomedical, Inc.: 1 (https://510kreport.com/company/georgia-biomedical)

## Firms that cite its devices most
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)

## Its most-cited devices
- K063546: Insuflow Device, Model 6198 (2007), cited by 5
- K090456: Insuflow (2009), cited by 4
- K120640: Insuflow Synergy Port (2012), cited by 3
- K101320: Vasovapor (2010), cited by 1
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (2014), cited by 1
- K132204: Insuflow Synergy XL Port (2013), cited by 1

## Recent decisions
- K191780: AP50/30 Insufflator with Insuflow Port (Aug 28, 2019)
- K170799: AP 50/30 Insufflator with Insuflow Port (Nov 14, 2017)
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (Mar 5, 2014)
- K132203: Pneuview XE Veryclear Gas Evacuation Cannula (Sep 20, 2013)
- K132204: Insuflow Synergy XL Port (Aug 22, 2013)
- K120640: Insuflow Synergy Port (Jul 18, 2012)
- K112357: Vessel Guardian (Nov 10, 2011)
- K102136: Vessel Guardian (Sep 27, 2010)

Source page: https://510kreport.com/company/lexion-medical