510(k) Report

510(k) · Cleared

Cleared

Bicard Mixing System

K030366510(k) TraditionalCleared Apr 19, 2004440-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

Dialysis Systems, Inc. · FIN Tank, Holding, Dialysis

Cleared on Apr 19, 2004 as substantially equivalent to K970674 (G.E.M. Water Systems, 1997) after a 440-day review. Its family tree reaches back 1 generation to 1997.

Decided
Apr 19, 2004
Review
440 days
Class
Class II
Product code
FIN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970674 (1997). No later device cites it as a predicate yet.

K970674 · G.E.M. Water Systems, International · G.E.M. Water Systems · 1997199619982000200220042006
K970674 · G.E.M. Water Systems, International · G.E.M. Water Systems · 19970
  1. Root · 1 generation backK970674 G.E.M. Water Systems, InternationalG.E.M. Water Systems · 1997
  2. This deviceK030366 Bicard Mixing SystemDialysis Systems, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970674G.E.M. Water Systems, InternationalG.E.M. Water Systems1997—
0 (this device)K030366Bicard Mixing SystemDialysis Systems, Inc.2004—
FIG. 1 — Lineage of K030366, 1997–2004Source: 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.

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970674G.E.M. Water Systems, International
Summary page 1
…ubstantial Equivalence: G.E.M. Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems 510(k)# K970674 Intended Use: This device is intended for the mixing of sodium bicarbonate powder with…
G.E.M. Water Systems1997—

Also cleared against K970674: 2 other devices →

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.
  • 2 other devices also cite its predicate K970674.

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?

The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

Indications for use as stated in the FDA summary.

Also cleared against K970674

2 other devices cite the same predicate.

  • K023011Osmonics Solution Delivery SystemOsmonics Medical Systems · 2003
  • K992793Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery SystemBetter Water, Inc. · 1999

More from Dialysis Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K822244NephrosolDialysis Systems, Inc. · 1982

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/K030366 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030366: Bicard Mixing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030366

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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