510(k) · Cleared
Recalled · Class II · 2012TANGO3 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 Dec 8, 2010 as substantially equivalent to K830575 (Renal Systems, Inc., 1983) and 3 other predicates after a 379-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 8, 2010
- Review
- 379 days
- Class
- Class II
- Product code
- FIN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K882564 (1989). 7 ancestors in all, the oldest K830575 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK882564 Renalin Cold SterilantMinntech Corp. · 1989
- 1 generation backK962959 Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc. · 1998
- This deviceK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010
- Descendant · cites it directly · 0 of its ownK140984 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
- Descendant · cites it directly · 0 of its ownK141213 Ameriwater Ozone Disinfection SystemAmeriwater · 2014
- Descendant · cites it directly · 0 of its ownK142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan…Ameriwater · 2014
Most influential descendants
Showing 3 of 3 · See all- K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015 · cites it directly0descendants
- K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014 · cites it directly0descendants
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882564 | Renalin Cold Sterilant | Minntech Corp. | 1989 | — |
| −1 | K962959 | Peracidin Dialyzer Reprocessing Concentrate | Hdc Medical, Inc. | 1998 | — |
| 0 (this device) | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | — |
| +1 | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
| +1 | K141213 | Ameriwater Ozone Disinfection System | Ameriwater | 2014 | — |
| +1 | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V… | Ameriwater | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 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? (6)
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 |
|---|---|---|---|
| * | K830575 | Renalin (TentativeSummary page 2…inntech Corporation) and other Peracetic Acid products such as Renalin® (K(830575) (Minintech Corporation) and Peracidin® (K962959) (AlcavisHDC) which are commonly used in hemodialysis clinics to disinfe… | 1983 |
| * | K962959 | Peracidin Dialyzer Reprocessing ConcentrateSummary page 2…oducts such as Renalin® (K(830575) (Minintech Corporation) and Peracidin® (K962959) (AlcavisHDC) which are commonly used in hemodialysis clinics to disinfect the reverse osmosis water purification… | 1998 |
| * | K043207 | Ozone GeneratorSummary page 2…with soak times of 30 minutes. Devices with equivalent intended use, technological characteristics and operational characteristics: 0 3Z (K(043207) - The O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructur… | 2005 |
| * | K974899 | Gambro Central Water Treatment System CWP 100 - Wro HSummary page 2…tion must be performed during non-operational hours just as TANGO 3. Devices with equivalent intended use and operational characteristics: *CWP 100 - WRO H (K974899) (heat disinfection unit for the distribution. loop only) - The CWP 100 - WRO H has a heat disinfection unit that produces… | 1998 |
| * | — | Minnecare® (Minntech Corporation) Named without a submission number | |
| * | — | Sodium hypochlorite at 500 ppm dilution Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2012 | Class II | Z-2138-2012 | Process control | During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K140984 (Tango3, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K830575.
How does its category compare?
All FIN devicesFIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TANGO 3 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 TANGO 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 ppmn and 0.3 ppm. The distribution system will be exposed to ozone for one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes with adequate water flushes between them and at the end, leaving the distribution loop without ozone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093641: 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 6, 2026. https://510kreport.com/device/K093641
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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