510(k) · Cleared
Recalled · 2011Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pure Water, Inc. · FIN Tank, Holding, Dialysis
Cleared on Apr 10, 2000 as substantially equivalent to K920186 (Better Water, Inc., 1995) and 1 other predicate after a 193-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 10, 2000
- Review
- 193 days
- Class
- Class II
- Product code
- FIN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920186 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920186 Water Purification System for HemodialysisBetter Water, Inc. · 1995
- This deviceK993272 Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK112427 Bicarb Mixing and Distribution SystemIsopure, Corp. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K112427Bicarb Mixing and Distribution SystemIsopure, Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920186 | Water Purification System for Hemodialysis | Better Water, Inc. | 1995 | — |
| 0 (this device) | K993272 | Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System | Pure Water, Inc. | 2000 | — |
| +1 | K112427 | Bicarb Mixing and Distribution System | Isopure, Corp. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K920186 | Water Purification System for HemodialysisSummary page 1…lysis Pure Water, Inc.’s Bicarb Mix, Storage and Distribution System is substantially equivalent to Better Water's Water Purification System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.’s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964… | 1995 |
| * | K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802…Summary page 1…n System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.’s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964539). which are currently in commercial distribution. Pure Water, Inc.’s Bicarb Mix, Storage and Distribution System uses Reverse Os… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112427 | Bicarb Mixing and Distribution System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2011 | Not classified | Z-0033-2012 | Software design | Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FIN devicesFIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIN
1in 2015
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIN
1in 2018
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 Pure Water, Inc.’s Bicarb Mix, Storage and Distribution system is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.
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/K993272 · printed Nov 3, 2026
Cite this page
510(k) Report. “K993272: Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K993272
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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