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

Cd Medical, Inc. — Predicate Candidate Screening

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

77 daysmedian FDA review time

152 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K925654	CD HOME DIALYSERVICE HEMODIALYSIS TRAY	Cd Medical, Inc.	1994-03-30	506	0
K910215	DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST	Cd Medical, Inc.	1991-04-09	82	5
K901520	WURTZ CHOLEY CLIP (TM)	Cd Medical, Inc.	1990-06-26	85	0
K894106	DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST	Cd Medical, Inc.	1989-11-08	152	0
K884353	ULTRX(TM) 850 ARTIFICIAL KIDNEY	Cd Medical, Inc.	1988-12-08	52	0
K880459	480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE	Cd Medical, Inc.	1988-04-13	70	0
K873279	8810 PUMP-PUMP SINGLE NEEDLE DEVICE	Cd Medical, Inc.	1987-10-23	67	0
K864784	SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS	Cd Medical, Inc.	1987-01-20	43	0
K862304	DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM	Cd Medical, Inc.	1986-09-09	84	0
K853513	DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY	Cd Medical, Inc.	1985-11-06	77	0
K844185	MODIFIED C-DAK	Cd Medical, Inc.	1985-01-03	66	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