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

Dynarex Corporation · Predicate Candidate Screening

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

155 daysmedian FDA review time

361 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172266	Dynarex Three-Way Stopcock	Dynarex Corporation	2018-03-14	230	0
K152970	Dynarex Xeroform Petrolatum Dressing	Dynarex Corporation	2016-10-03	361	0
K151575	Dynarex Eye Cups	Dynarex Corporation	2015-09-01	82	0
K103086	DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC	Dynarex Corporation	2011-06-07	231	0
K102637	DYNAREX ULTRASOUND GEL	Dynarex Corporation	2011-02-16	155	0
K092488	DYNAREX STERILE LUBRICATING JELLY	Dynarex Corporation	2009-12-18	127	1
K082863	DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAR	Dynarex Corporation	2009-01-09	102	0
K081569	DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIE	Dynarex Corporation	2008-09-12	100	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