510(k) Report

510(k) · Cleared

Cleared

Mar Cor Services Bicarb System

K003560510(k) TraditionalCleared Jun 8, 2001203-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

Mar Cor Services, Inc. · FIN Tank, Holding, Dialysis

Cleared on Jun 8, 2001 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 8, 2001
Review
203 days
Class
Class II
Product code
FIN
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2006: 1 descendant cleared200020052010201520202025
  1. This deviceK003560 Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK031502 Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter · 2004
  3. Descendant · 2 generations on · 0 of its ownK060333 Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006
  4. Descendant · cites it directly · 0 of its ownK033118 Bipro Model SDS-CB200Medical Solutions International · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K031502Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter · 2004 · cites it directly1descendant
  • K060333Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006 · 2 generations on0descendants
  • K033118Bipro Model SDS-CB200Medical Solutions International · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003560Mar Cor Services Bicarb SystemMar Cor Services, Inc.2001—
+1K031502Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter2004—
+2K060333Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc.2006—
+1K033118Bipro Model SDS-CB200Medical Solutions International2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200610
FIG. 1 — Lineage of K003560, 2001–2006Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031502Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter20041
K033118Bipro Model SDS-CB200Medical Solutions International20040

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?

  • Of its descendants, K031502 (Usfilter, 2004) has gone furthest, with 1 descendant of its own.

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—

More from Mar Cor Services, Inc.

3 FDA decisions under this applicant name. See the company

  • K003877Mar Cor Services Semper Pure RO MachineMar Cor Services, Inc. · 2001
  • K945559Mar Cor Complete Water Treatment System for Kdney DialysisMar Cor Services, Inc. · 1996

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/K003560 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003560: Mar Cor Services Bicarb System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003560

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026