TANGO3 Water Storage Tank with Ozone Disinfection System
510(k) K140984
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140984 | Date12 Jan 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FIN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Holding Tank, Dialysis, designed to store and disinfect water used in hemodialysis facilities. It incorporates an ozone disinfection system to generate and distribute ozonated water through the facility’s water distribution loop during non-operational hours, reducing microbial contamination in the stored water supply. The system is classified under FDA regulation 876.5820 and falls under Class II medical devices, intended for use in gastroenterology and urology settings.
The Tango3 Water Storage Tank with Ozone Disinfection System is supplied as a reusable, non-sterile medical device for installation in dialysis facilities. It operates by filling the tank with water and inducing ozone to maintain disinfection levels during off-hours, ensuring water safety for dialysis procedures. The device is authorized for use in the U.S. via an FDA 510(k) clearance (K140984) and is intended for integration into existing water distribution systems without requiring additional sterility measures beyond standard facility protocols.
Other devices from Tango3, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Tango3 Water Storage Tank with Ozone Disinfection System used for?
This device is designed specifically for hemodialysis facilities to store and disinfect water used in dialysis procedures. It incorporates an ozone disinfection system that generates and distributes ozonated water through the facility’s water distribution loop during non-operational hours. This process helps reduce microbial contamination in stored water, ensuring a safer water supply for dialysis treatments.
How is the Tango3 Water Storage Tank with Ozone Disinfection System supplied?
The device is supplied as a reusable, non-sterile medical product. It is intended for installation in dialysis facilities and is not pre-sterilized. Standard facility protocols for water treatment and maintenance should be followed to ensure proper functionality and safety.
Does the Tango3 Water Storage Tank require additional sterility measures beyond standard facility protocols?
No, the device does not require additional sterility measures beyond what is already part of standard facility protocols. It is designed to integrate into existing water distribution systems, relying on its ozone disinfection system to maintain water safety during off-hours.
Can the Tango3 Water Storage Tank be used in settings other than dialysis facilities?
While the device is FDA-cleared for use in hemodialysis facilities under regulation 876.5820, its primary intended use is within these settings. The system is specifically engineered for integration into dialysis water distribution loops to ensure microbial safety in stored water. Consult manufacturer guidelines for off-label considerations.
How does the ozone disinfection system work in this water storage tank?
The ozone disinfection system in the Tango3 Water Storage Tank generates ozone gas, which is then dissolved into the stored water. During non-operational hours, this ozonated water is circulated through the facility’s distribution loop, effectively reducing microbial contamination. The system ensures continuous water safety without requiring additional sterility measures beyond routine facility maintenance.