Product Code: FIN FDA class 2 21 CFR 876.5820

Tank, Holding, Dialysis

Gastroenterology, Urology

The Dialysis Holding Tank is a reservoir component of a hemodialysis system used to store dialysate solution before it is delivered to the dialyzer during treatment. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FIN, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FIN
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K140984	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	Jan 12, 2015	Substantially Equivalent	Tango3, LLC
K141213	AMERIWATER OZONE DISINFECTION SYSTEM	Dec 10, 2014	Substantially Equivalent	Ameriwater
K112427	BICARB MIXING AND DISTRIBUTION SYSTEM	Jan 26, 2012	Substantially Equivalent	Isopure, Corp.
K093641	TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM	Dec 08, 2010	Substantially Equivalent	Tango3, LLC
K060333	DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM	Sep 08, 2006	Substantially Equivalent	Dialysis Services, Inc.
K051031	AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS	Jan 06, 2006	Substantially Equivalent	Ameriwater
K031502	USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM	Aug 27, 2004	Substantially Equivalent	Usfilter
K033118	BIPRO MODEL SDS-CB200	Jun 28, 2004	Substantially Equivalent	Medical Solutions International
K030366	BICARD MIXING SYSTEM	Apr 19, 2004	Substantially Equivalent	Dialysis Systems, Inc.
K023011	OSMONICS SOLUTION DELIVERY SYSTEM	Jun 26, 2003	Substantially Equivalent	Osmonics Medical Systems
K003560	MAR COR SERVICES BICARB SYSTEM	Jun 08, 2001	Substantially Equivalent	Mar Cor Services, Inc.
K993272	PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM	Apr 10, 2000	Substantially Equivalent	Pure Water, Inc.
K993058	PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL	Jan 24, 2000	Substantially Equivalent	Pure Water, Inc.
K992793	SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM	Nov 16, 1999	Substantially Equivalent	Better Water, Inc.
K970674	G.E.M. WATER SYSTEMS, INTERNATIONAL	Nov 19, 1997	Substantially Equivalent	G.E.M. Water Systems
K961416	DIALYSIS MIXING & HOLDING TANK	Aug 21, 1996	Substantially Equivalent	Dial Medical Supply
K883408	NATURALYTE MIXER	Oct 31, 1988	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K873166	BCM DRY PACK BICARBONATE MIXER	Dec 30, 1987	Substantially Equivalent	Specialty Dialysis Services