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

Reverse Medical Corporation · Predicate Candidate Screening

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

92 daysmedian FDA review time

233 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K150108	Reverse Medical Micro Vascular Plug System	Reverse Medical Corporation	2015-04-22	92
K141313	REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM	Reverse Medical Corporation	2014-06-18	29
K133282	REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM	Reverse Medical Corporation	2013-11-27	33
K130858	REVERSE MEDICAL MICROCATHETER	Reverse Medical Corporation	2013-10-11	197
K123803	REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM	Reverse Medical Corporation	2013-07-02	204
K122684	REVERSE MEDICAL MICROCATHETER	Reverse Medical Corporation	2012-12-07	98
K112262	REFLEX BALLON GUIDE CATHETER	Reverse Medical Corporation	2011-11-02	86
K102418	REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM	Reverse Medical Corporation	2011-04-15	233
K110055	REVERSE MEDICAL REFLEX GUIDE CATHETER	Reverse Medical Corporation	2011-04-05	85
K091563	RECRUIT MICROCATHETER	Reverse Medical Corporation	2009-07-30	63

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