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

FIN — Predicate Candidate Screening

18 FDA 510(k) clearances under this product code; the 50 most recent screened below.

212 daysmedian FDA review time

440 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K140984	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	Tango3, LLC	2015-01-12	271	0
K141213	AMERIWATER OZONE DISINFECTION SYSTEM	Ameriwater	2014-12-10	212	0
K112427	BICARB MIXING AND DISTRIBUTION SYSTEM	Isopure, Corp.	2012-01-26	156	1
K093641	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	Tango3, LLC	2010-12-08	379	1
K060333	DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUT	Dialysis Services, Inc.	2006-09-08	211	0
K051031	AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIAL	Ameriwater	2006-01-06	259	0
K031502	USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM	Usfilter	2004-08-27	472	0
K033118	BIPRO MODEL SDS-CB200	Medical Solutions International	2004-06-28	272	0
K030366	BICARD MIXING SYSTEM	Dialysis Systems, Inc.	2004-04-19	440	0
K023011	OSMONICS SOLUTION DELIVERY SYSTEM	Osmonics Medical Systems	2003-06-26	290	0
K003560	MAR COR SERVICES BICARB SYSTEM	Mar Cor Services, Inc.	2001-06-08	203	0
K993272	PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYST	Pure Water, Inc.	2000-04-10	193	1
K993058	PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM W	Pure Water, Inc.	2000-01-24	133	0
K992793	SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRA	Better Water, Inc.	1999-11-16	89	0
K970674	G.E.M. WATER SYSTEMS, INTERNATIONAL	G.E.M. Water Systems	1997-11-19	268	0
K961416	DIALYSIS MIXING & HOLDING TANK	Dial Medical Supply	1996-08-21	131	0
K883408	NATURALYTE MIXER	National Medical Care, Medical Products Div., Inc.	1988-10-31	81	0
K873166	BCM DRY PACK BICARBONATE MIXER	Specialty Dialysis Services	1987-12-30	141	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