510(k) · Cleared
Recalled · Class II · 2022Bicarb Mixing and Distribution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isopure, Corp. · FIN Tank, Holding, Dialysis
Cleared on Jan 26, 2012 as substantially equivalent to K993272 (Pure Water, Inc., 2000) after a 156-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 2 times.
- Decided
- Jan 26, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- FIN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920186 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920186 | Water Purification System for Hemodialysis | Better Water, Inc. | 1995 | — |
| −1 | K993272 | Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System | Pure Water, Inc. | 2000 | 1 |
| 0 (this device) | K112427 | Bicarb Mixing and Distribution System | Isopure, Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 | Decided |
|---|---|---|---|
| * | K993272 | Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemSummary page 1…f Technological Characteristics and Those of Predicate Devices: The technological characteristics of the device are the same as the original submitted deviceunder 501(k) K993272, Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System cleared on April 10, 2000.… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2022 | Class II | Z-1360-2022 | Other | Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety… |
| Apr 19, 2019 | Class II | Z-0822-2020 | Nonconforming Material/Component | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FIN devicesFIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Isopure Sodium Bicarbonate Mixing 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 as stated in the FDA summary.
https://510kreport.com/device/K112427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112427: Bicarb Mixing and Distribution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112427
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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