Atlas FDA

FIN

18 FDA 510(k) clearances · Product code

212 daysmedian time to decision
440 days90th percentile
18clearances measured

FDA profile

Official device name
Tank, Holding, Dialysis
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K140984)Tango3, LLC2015-01-12
AMERIWATER OZONE DISINFECTION SYSTEM (K141213)Ameriwater2014-12-10
BICARB MIXING AND DISTRIBUTION SYSTEM (K112427)Isopure, Corp.2012-01-26
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K093641)Tango3, LLC2010-12-08
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (K060333)Dialysis Services, Inc.2006-09-08
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (K051031)Ameriwater2006-01-06
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (K031502)Usfilter2004-08-27
BIPRO MODEL SDS-CB200 (K033118)Medical Solutions International2004-06-28
BICARD MIXING SYSTEM (K030366)Dialysis Systems, Inc.2004-04-19
OSMONICS SOLUTION DELIVERY SYSTEM (K023011)Osmonics Medical Systems2003-06-26
MAR COR SERVICES BICARB SYSTEM (K003560)Mar Cor Services, Inc.2001-06-08
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM (K993272)Pure Water, Inc.2000-04-10
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL (K993058)Pure Water, Inc.2000-01-24
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM (K992793)Better Water, Inc.1999-11-16
G.E.M. WATER SYSTEMS, INTERNATIONAL (K970674)G.E.M. Water Systems1997-11-19
DIALYSIS MIXING & HOLDING TANK (K961416)Dial Medical Supply1996-08-21
NATURALYTE MIXER (K883408)National Medical Care, Medical Products Div., Inc.1988-10-31
BCM DRY PACK BICARBONATE MIXER (K873166)Specialty Dialysis Services1987-12-30

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Every clearance here is in the API, with alerts when new ones post.