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

Clinical Resources, Inc. — Predicate Candidate Screening

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

72 daysmedian FDA review time

101 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K941470	TRACHEOSTOMY CARE KIT	Clinical Resources, Inc.	1995-02-14	323
K944882	IRRIGATION TRAY	Clinical Resources, Inc.	1995-01-12	101
K944881	SKIN SCRUB TRAY	Clinical Resources, Inc.	1994-12-27	85
K945019	FLUFF GAUXZE ROLL	Clinical Resources, Inc.	1994-12-23	72
K945020	FLUFF GAUZE SPONGE	Clinical Resources, Inc.	1994-12-23	72
K944879	GAUZE SPONGES	Clinical Resources, Inc.	1994-12-23	81
K945021	FLUFF GAUZE SPONGE	Clinical Resources, Inc.	1994-12-23	72
K944880	BODILY FLUID DISPOSAL KIT	Clinical Resources, Inc.	1994-12-15	73
K941471	CENTRAL LINE DRESSING CHANGE TRAY	Clinical Resources, Inc.	1994-05-12	45
K941469	IV START KIT	Clinical Resources, Inc.	1994-05-12	45
K941468	DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY	Clinical Resources, Inc.	1994-05-12	45
K941467	WOUND DRESSING KIT	Clinical Resources, Inc.	1994-05-12	45
K941466	SURGICAL INSTRUMENTS KIT	Clinical Resources, Inc.	1994-04-22	25
K941465	SUTURE REMOVAL KIT	Clinical Resources, Inc.	1994-04-22	25

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