510(k) · Cleared
ClearedOzone Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Infrastructure Water & Process Technologies · NII Disinfectant, Dialysate Delivery System
Cleared on Nov 4, 2005 as substantially equivalent to K873200 (Life Enhancement Technologies, LLC, 1989) and 1 other predicate after a 350-day review. Its family tree reaches back 1 generation to 1983. 4 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 350 days
- Class
- Class II
- Product code
- NII
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830575 (1983). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830575 Renalin (TentativeRenal Systems, Inc. · 1983
- This deviceK043207 Ozone GeneratorGe Infrastructure Water & Process Technologies · 2005
- Descendant · cites it directly · 3 of its ownK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan…Ameriwater · 2014
Most influential descendants
Showing 4 of 4 · See all- K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · cites it directly3descendants
- K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015 · 2 generations on0descendants
- K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014 · cites it directly0descendants
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830575 | Renalin (Tentative | Renal Systems, Inc. | 1983 | — |
| 0 (this device) | K043207 | Ozone Generator | Ge Infrastructure Water & Process Technologies | 2005 | — |
| +1 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| +2 | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
| +1 | K141213 | Ameriwater Ozone Disinfection System | Ameriwater | 2014 | — |
| +2 | 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 |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 NII? 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? (3)
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 |
|---|---|---|---|
| * | K873200 | Karlson Ozone Sterilizer Model 100BSummary page 2…The ozone generator for system disinfection is substantially equivalent in technological characteristics of the Karlson Ozone Sterilizer (K873200). It is substantially equivalent in intended use to Minncore®, which is commonly used in hemodialysis clinics to dis… | 1989 |
| * | K830575 | Renalin (TentativeSummary page 2…mmonly used in hemodialysis clinics to disinfect the reverse osmosis water purification equipment and the water distribution loop and Renalin® (K830575), another common disinfectant used in dialysis clinics primarily to reprocess dialgzers and disinfect dialysis machi… | 1983 |
| * | — | Minncore® Named without a submission number |
What descends from it? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K093641 (Tango3, LLC, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NII devicesNII Disinfectant, Dialysate Delivery System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NII
FDA has decided no NII device since 2007.
Median 510(k) review, days · NII
Too few NII 510(k)s in any year since 2007 to give a median.
Recalls per year · NII
No recall names NII since 2007.
Adverse event reports per year · NII
1in 2025
MAUDE reports naming product code NII, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043207: Ozone Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043207
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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