Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Lexion Medical, LLC · Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

66 daysmedian FDA review time

184 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K191780	AP50/30 Insufflator with Insuflow Port	Lexion Medical, LLC	2019-08-28	57
K170799	AP 50/30 Insufflator with Insuflow Port	Lexion Medical, LLC	2017-11-14	242
K140263	INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT	Lexion Medical, LLC	2014-03-05	30
K132203	PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA	Lexion Medical, LLC	2013-09-20	66
K132204	INSUFLOW SYNERGY XL PORT	Lexion Medical, LLC	2013-08-22	37
K120640	INSUFLOW SYNERGY PORT	Lexion Medical, LLC	2012-07-18	138
K112357	VESSEL GUARDIAN	Lexion Medical, LLC	2011-11-10	86
K102136	VESSEL GUARDIAN	Lexion Medical, LLC	2010-09-27	60
K101320	VASOVAPOR	Lexion Medical, LLC	2010-06-24	44
K091366	INSUFLOW DEWHEART	Lexion Medical, LLC	2009-09-03	118
K090456	INSUFLOW	Lexion Medical, LLC	2009-08-26	184
K090879	INSUFLOW CO2IONSHIELD	Lexion Medical, LLC	2009-07-23	114
K063546	INSUFLOW DEVICE, MODEL 6198	Lexion Medical, LLC	2007-01-10	47

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda