510(k) Report

510(k) · Cleared

Cleared

Bipro Model SDS-CB200

K033118510(k) TraditionalCleared Jun 28, 2004272-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

Medical Solutions International · FIN Tank, Holding, Dialysis

Cleared on Jun 28, 2004 as substantially equivalent to K003560 (Mar Cor Services, Inc., 2001) after a 272-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 28, 2004
Review
272 days
Class
Class II
Product code
FIN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003560 (2001). No later device cites it as a predicate yet.

K003560 · Mar Cor Services Bicarb System · Mar Cor Services, Inc. · 20012000200220042006
K003560 · Mar Cor Services Bicarb System · Mar Cor Services, Inc. · 20010
  1. Root · 1 generation backK003560 Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 2001
  2. This deviceK033118 Bipro Model SDS-CB200Medical Solutions International · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003560Mar Cor Services Bicarb SystemMar Cor Services, Inc.2001—
0 (this device)K033118Bipro Model SDS-CB200Medical Solutions International2004—
FIG. 1 — Lineage of K033118, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003560Mar Cor Services Bicarb System
Summary page 2
…cal Solutions BiPro Model is substantially equivalent in intended use, features, functions, and technological characteristics to the Mar Cor Services, Inc Bicarb System (K003560) Performance: Safety and Effectiveness Information: Medical Solutions BiPro Systems have been voluntarily tested to meet the saf…
Mar Cor Services, Inc.2001—

Also cleared against K003560: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 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

2010: 12012: 12014: 12015: 1
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

2019: 1
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

2015: 12017: 12018: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20121—00
20130—00
20141—00
20151—01
20160—00
20170—01
20180—01
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.

Indications for use as stated in the FDA summary.

Also cleared against K003560

1 other device cites the same predicate.

  • K031502Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter · 2004

Recent decisions in FIN

The FIN category page

  • K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
  • K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014
  • K112427Bicarb Mixing and Distribution SystemIsopure, Corp. · 20122 recalls
  • K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 20101 recall
  • K060333Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006

https://510kreport.com/device/K033118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033118: Bipro Model SDS-CB200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033118

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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