510(k) Report

FDA applicant

Lexion Medical, LLC

St. Paul, MN13 decisions2007–20190 recalls

FDA records 13 decisions for Lexion Medical, LLC (St. Paul, MN) from 2007 to 2019: 13 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and FCX (Insufflator, Automatic Carbon-Dioxide For…). Its devices cite 31 predicates, 16 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Lexion Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12009: 32010: 22011: 12012: 12013: 22014: 12017: 12019: 1
2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lexion Medical, LLC 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?

  • HIFInsufflator, Laparoscopic12decisions
  • FCXInsufflator, Automatic Carbon-Dioxide For Endoscope1decision

Whose devices does it build on?

Its devices cite 31 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 16 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.

  • K063546Insuflow Device, Model 6198Lexion Medical, LLC · 20075cite it
  • K090456InsuflowLexion Medical, LLC · 20094cite it
  • K120640Insuflow Synergy PortLexion Medical, LLC · 20123cite it
  • K101320VasovaporLexion Medical, LLC · 20101cites it
  • K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 20141cites it
  • K132204Insuflow Synergy XL PortLexion Medical, LLC · 20131cites it

What has FDA decided for it lately?

  • K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019
  • K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
  • K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
  • K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC · 2013
  • K132204Insuflow Synergy XL PortLexion Medical, LLC · 2013
  • K120640Insuflow Synergy PortLexion Medical, LLC · 2012
  • K112357Vessel GuardianLexion Medical, LLC · 2011
  • K102136Vessel GuardianLexion Medical, LLC · 2010

All 13 as Lexion Medical, LLC →