510(k) · Cleared
ClearedDialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dialysis Services, Inc. · FIN Tank, Holding, Dialysis
Cleared on Sep 8, 2006 as substantially equivalent to K031502 (Usfilter, 2004) after a 211-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 8, 2006
- Review
- 211 days
- Class
- Class II
- Product code
- FIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003560 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003560 Mar Cor Services Bicarb SystemMar Cor Services, Inc. · 2001
- 1 generation backK031502 Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemUsfilter · 2004
- This deviceK060333 Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution SystemDialysis Services, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003560 | Mar Cor Services Bicarb System | Mar Cor Services, Inc. | 2001 | — |
| −1 | K031502 | Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System | Usfilter | 2004 | — |
| 0 (this device) | K060333 | Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System | Dialysis Services, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K031502 | Usfilter Bicarbonate Mixing and Dispensing (Bicarb) SystemSummary page 1…78 HIP 4.8 Predicate Device: USFilter Bicarbonate Mixing and Dispensing System K031 502 4,9 Device Description: Device isdesigned to provide the user with a system for… | 2004 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
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 bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060333: Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060333
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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