510(k) · Cleared
ClearedTANGO3 Water Storage Tank with Ozone Disinfection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tango3, LLC · FIN Tank, Holding, Dialysis
Cleared on Jan 12, 2015 as substantially equivalent to K093641 (Tango3, LLC, 2010) after a 271-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Jan 12, 2015
- Review
- 271 days
- Class
- Class II
- Product code
- FIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K882564 (1989). 8 ancestors in all, the oldest K830575 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK882564 Renalin Cold SterilantMinntech Corp. · 1989
- 2 generations backK962959 Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc. · 1998
- 1 generation backK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- This deviceK140984 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882564 | Renalin Cold Sterilant | Minntech Corp. | 1989 | — |
| −2 | K962959 | Peracidin Dialyzer Reprocessing Concentrate | Hdc Medical, Inc. | 1998 | — |
| −1 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| 0 (this device) | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection SystemSummary page 7…PROPOSED DEVICE: Tank with Ozone Disinfection System TANGO3, LLC TANGO3 Water Storage PARAMETER K093641 Tank with Ozone Disinfection System Classification Name And Hemodialysis System and… | 2010 |
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 26 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K093641.
How does its category compare?
All FIN devicesFIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water…
Read the full statement (141 words)
The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140984: TANGO3 Water Storage Tank with Ozone Disinfection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140984
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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