510(k) · Cleared
ClearedAirocide TI02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kes Science & Technology, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Feb 4, 2003 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Feb 4, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- Descendant · cites it directly · 16 of its ownK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- Descendant · cites it directly · 15 of its ownK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- Descendant · 3 generations on · 11 of its ownK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- Descendant · 4 generations on · 9 of its ownK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K033448Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004 · cites it directly16descendants
- K052732Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30PAbracair, Inc. · 2006 · cites it directly15descendants
- K161468Transformair Indoor Air PurifierTransformair, LLC · 2017 · 2 generations on14descendants
- K200500Molekule Air Pro RXMolekule, Inc. · 2020 · 3 generations on11descendants
- K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| +1 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| +1 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| +2 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| +3 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| +4 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRA? 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 FRA device
- #1 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 172 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?
- Of its descendants, K033448 (John Mfg., Ltd., 2004) has gone furthest, with 16 descendants of its own.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AiroCide Ti02 INTENDED USE: Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, hulding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities. etc
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023830: Airocide TI02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023830
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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