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

Cush Medical Products · Predicate Candidate Screening

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

76 daysmedian FDA review time

160 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K943424	CUSH ISLAND DRESSING	Cush Medical Products	1994-10-03	80
K940518	C-SECTION TRAY	Cush Medical Products	1994-08-18	195
K941349	DENTAL TRAY	Cush Medical Products	1994-07-26	127
K941645	BIOPSY TRAY	Cush Medical Products	1994-07-14	101
K940239	EYE TRAY	Cush Medical Products	1994-06-28	160
K935684	IV START KIT	Cush Medical Products	1994-06-10	193
K941455	STERILE GAUZE PRODUCT LINE	Cush Medical Products	1994-05-20	56
K941344	LAP SPONGE PRODUCT LINE	Cush Medical Products	1994-05-12	56
K941522	STERILE X-RAY DETECTABLE GAUZE SPONGES	Cush Medical Products	1994-05-12	43
K935697	CIRCUMCISION TRAY	Cush Medical Products	1994-05-02	153
K936120	LABOR AND DELIVERY TRAY	Cush Medical Products	1994-03-30	97
K940444	GENERAL SURGERY TRAY	Cush Medical Products	1994-03-07	34
K935743	INSTRUMENT TRAY	Cush Medical Products	1994-03-03	92
K936117	CENTRAL LINE TRAY	Cush Medical Products	1994-03-01	68
K935686	DRESSING CHANGE TRAY	Cush Medical Products	1994-02-25	88
K935740	IRRIGATION TRAY	Cush Medical Products	1994-02-22	83
K935741	O.R. BASIN SET TRAY	Cush Medical Products	1994-02-15	76
K935683	SUTURE REMOVAL TRAY	Cush Medical Products	1994-02-10	73
K935682	LACERATION TRAY	Cush Medical Products	1994-02-10	73
K935742	SKIN SCRUB TRAY	Cush Medical Products	1994-02-10	71
K935685	TRACHEOSTOMY CARE TRAY	Cush Medical Products	1994-02-10	73
K935681	INCISION/DRAINAGE TRAY	Cush Medical Products	1994-02-10	73
K935739	SHAVE PREP TRAY	Cush Medical Products	1994-02-09	70

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