510(k) · Cleared
ClearedKarlson Ozone Sterilizer Model 100B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Enhancement Technologies, LLC · FLF Sterilizer, Ethylene-Oxide Gas
Cleared on Jan 27, 1989 after a 533-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 27, 1989
- Review
- 533 days
- Class
- Class II
- Product code
- FLF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK873200 Karlson Ozone Sterilizer Model 100BLife Enhancement Technologies, LLC · 1989
- Descendant · cites it directly · 4 of its ownK043207 Ozone GeneratorGe Infrastructure Water & Process Technologies · 2005
- Descendant · 2 generations on · 3 of its ownK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
- Descendant · 3 generations on · 0 of its ownK140984 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK141213 Ameriwater Ozone Disinfection SystemAmeriwater · 2014
- Descendant · 3 generations on · 0 of its ownK142285 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan…Ameriwater · 2014
Most influential descendants
Showing 5 of 5 · See all- K043207Ozone GeneratorGe Infrastructure Water & Process Technologies · 2005 · cites it directly4descendants
- K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · 2 generations on3descendants
- K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2015 · 3 generations on0descendants
- K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014 · 2 generations on0descendants
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873200 | Karlson Ozone Sterilizer Model 100B | Life Enhancement Technologies, LLC | 1989 | — |
| +1 | K043207 | Ozone Generator | Ge Infrastructure Water & Process Technologies | 2005 | — |
| +2 | K093641 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2010 | 1 |
| +3 | K140984 | TANGO3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | 2015 | — |
| +2 | K141213 | Ameriwater Ozone Disinfection System | Ameriwater | 2014 | — |
| +3 | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V… | Ameriwater | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLF device
- #1 K192978 EOGas 4 Ethylene Oxide Gas Sterilizerscore 0.6 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043207 | Ozone Generator | 2005 | 4 |
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?
- Of its descendants, K043207 (Ge Infrastructure Water & Process Technologies, 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FLF
Too few FLF 510(k)s in any year since 2007 to give a median.
Recalls per year · FLF
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLF
4in 2021
MAUDE reports naming product code FLF, 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 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 0 | — | 2 | 6 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K873200 · printed Nov 5, 2026
Cite this page
510(k) Report. “K873200: Karlson Ozone Sterilizer Model 100B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K873200
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026