# K093641: TANGO3 Water Storage Tank with Ozone Disinfection System

- Pathway: 510(k) (Traditional)
- Applicant: Tango3, LLC
- Decided: Dec 8, 2010 after 379 days
- Product code: FIN (Tank, Holding, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882564 (1989). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830575: Renalin (Tentative, Renal Systems, Inc. (1983) Summary page 2.
- K962959: Peracidin Dialyzer Reprocessing Concentrate, Hdc Medical, Inc. (1998) Summary page 2.
- K043207: Ozone Generator, Ge Infrastructure Water & Process Technologies (2005) Summary page 2.
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H, Gambro Healthcare (1998) Summary page 2.
- (no number) Minnecare® (Minntech Corporation): named in the summary without a submission number
- (no number) Sodium hypochlorite at 500 ppm dilution: named in the summary without a submission number

## Most influential descendants
- K140984: TANGO3 Water Storage Tank with Ozone Disinfection System (2015), 0 descendants of its own
- K141213: Ameriwater Ozone Disinfection System (2014), 0 descendants of its own
- K142285: AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz (2014), 0 descendants of its own

## Recalls of this device
- Mar 26, 2012 · Class II · Z-2138-2012: 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 recei

## Indications for use
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.

Source page: https://510kreport.com/device/K093641
Methodology: https://510kreport.com/methodology