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

Rex Medical · Predicate Candidate Screening

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

119 daysmedian FDA review time

314 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120346	CLEANER ROTATIONAL THROMBECTOMY SYSTEM	Rex Medical	2012-06-01	119	0
K113103	SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVI	Rex Medical	2012-05-22	216	0
K102043	ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER	Rex Medical	2010-11-18	121	3
K091029	CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9	Rex Medical	2010-02-18	314	0
K081410	OPTION VENA CAVA FILTER	Rex Medical	2009-06-04	380	0
K071422	15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET	Rex Medical	2007-08-22	92	0
K051468	INNER-LOCK INTRODUCER SHEATH	Rex Medical	2005-08-04	62	0
K040252	CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT	Rex Medical	2004-02-26	22	0
K033793	CLEANER II ROTATIONAL THROMBECTOMY SYSTEM	Rex Medical	2003-12-16	11	0
K032569	SHORT INTRODUCER SHEATH	Rex Medical	2003-09-16	27	0
K031610	REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM	Rex Medical	2003-05-27	5	1
K023847	HEMO-STREAM HEMODIALYSIS CATHETER SET	Rex Medical	2003-04-30	162	3
K022170	INNER-LOCK LOCKING INTRODUCER SHEATHS	Rex Medical	2003-01-21	202	0

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