510(k) · Cleared

Cleared

Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System

K031502510(k) TraditionalCleared Aug 27, 2004472-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Usfilter · FIN Tank, Holding, Dialysis

Cleared on Aug 27, 2004 as substantially equivalent to K003560 (Mar Cor Services, Inc., 2001) after a 472-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Aug 27, 2004
Review: 472 days
Class: Class II
Product code: FIN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003560 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003560 Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 2001
This deviceK031502 Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter · 2004
Descendant · cites it directly · 0 of its ownK060333 Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K060333Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003560	Mar Cor Services Bicarb System	Mar Cor Services, Inc.	2001	—
0 (this device)	K031502	Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System	Usfilter	2004	—
+1	K060333	Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System	Dialysis Services, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K031502, 2001–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K003560	Mar Cor Services Bicarb System Summary page 1 …SFilter Bicarbonate Mixing and Dispensing (Bicarb) System 4 Substantial Equivalence MAR COR Services, Inc. MAR COR Services Bicarb System K003560 5 Device Description The consistent mixing and delivery of bicarbonate solution for use in hemodialysis 6…	Mar Cor Services, Inc.	2001	—

Also cleared against K003560: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060333	Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System	Dialysis Services, Inc.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K060333 (Dialysis Services, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K003560.

How does its category compare?

All FIN devices

FIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIN

1in 2015

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIN

Too few FIN 510(k)s in any year since 2007 to give a median.

Recalls per year · FIN

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FIN

1in 2018

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code FIN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	1	—	0	0
2015	1	—	0	1
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	1
2019	0	—	1	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a

Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing

and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031502 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031502: Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031502

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026