510(k) · Cleared

Cleared

Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System

K992793510(k) TraditionalCleared Nov 16, 199989-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

Better Water, Inc. · FIN Tank, Holding, Dialysis

Cleared on Nov 16, 1999 as substantially equivalent to K970674 (G.E.M. Water Systems, 1997) after an 89-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Nov 16, 1999
Review: 89 days
Class: Class II
Product code: FIN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970674 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970674 G.E.M. Water Systems, InternationalG.E.M. Water Systems · 1997
This deviceK992793 Sodium Bicarbonate Mixing/Delivery System, and the Concentrate…Better Water, Inc. · 1999
Descendant · cites it directly · 0 of its ownK051031 Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater · 2006

Most influential descendants

Showing 1 of 1 · See all

K051031Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970674	G.E.M. Water Systems, International	G.E.M. Water Systems	1997	—
0 (this device)	K992793	Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System	Better Water, Inc.	1999	—
+1	K051031	Ameriwater Solution Mix and Distribution System for Hemodialysis	Ameriwater	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K992793, 1997–2006Source: 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
*	K970674	G.E.M. Water Systems, International Summary page 1 …ystem for Dialysis, Central Bicarbonate Mixing/Delivery System. Substantial Equivalence: G.E.M Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems #K970674 Classification Name: “Hemodialysis System and Accessories” (21 CFR 876.5820) Intended Use: These devices are intended to be use…	G.E.M. Water Systems	1997	—

Also cleared against K970674: 2 other devices →

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
K051031	Ameriwater Solution Mix and Distribution System for Hemodialysis	Ameriwater	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, K051031 (Ameriwater, 2006) has gone furthest, with 0 descendants of its own.
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

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 INTENDED USE OF THESE DEVICES IS TO ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PURIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES. IT IS ALSO INTENDED TO AUTOMATICALLY DELIVER A PRE-MIXED CONCENTRATE SOLUTION TQ,-THE DIALYSIS MACHINE.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992793 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992793: Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992793

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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