# K043207: Ozone Generator

- Pathway: 510(k) (Traditional)
- Applicant: Ge Infrastructure Water & Process Technologies
- Decided: Nov 4, 2005 after 350 days
- Product code: NII (Disinfectant, Dialysate Delivery System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830575 (1983). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873200: Karlson Ozone Sterilizer Model 100B, Life Enhancement Technologies, LLC (1989) Summary page 2.
- K830575: Renalin (Tentative, Renal Systems, Inc. (1983) Summary page 2.
- (no number) Minncore®: named in the summary without a submission number

## Most influential descendants
- K093641: TANGO3 Water Storage Tank with Ozone Disinfection System (2010), 3 descendants of its own
- 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

## Indications for use
The 03Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process the system is then rinsed with RO or deionized water until the system is residual free of ozone.

Source page: https://510kreport.com/device/K043207
Methodology: https://510kreport.com/methodology