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

Z-Medica Corporation — Predicate Candidate Screening

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

27 daysmedian FDA review time

370 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K120782	INTERVENTIONAL HEMOSTATIC BANDAGE	Z-Medica Corporation	2013-03-20	370
K090620	QUIKCLOT INTEVENTIONAL, MODEL P/N 182	Z-Medica Corporation	2009-04-08	30
K080247	QUIKCLOT NOSEBLEED	Z-Medica Corporation	2008-02-27	27
K072474	QUIKCLOT EX	Z-Medica Corporation	2007-10-16	42
K070010	QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER	Z-Medica Corporation	2007-01-25	22
K061767	QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+	Z-Medica Corporation	2006-07-19	26
K051955	QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE	Z-Medica Corporation	2005-08-10	22
K050769	QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATIO	Z-Medica Corporation	2005-04-14	20

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