510(k) · Cleared
ClearedAirKEE T900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healkee Medical Pte, Ltd. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on May 23, 2024 as substantially equivalent to K212644 (Invictus Lighting, 2022) after a 267-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- May 23, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K023830 (2003). No later device cites it as a predicate yet.
- Root · 7 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 6 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 5 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 4 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 3 generations backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- 2 generations backK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- 1 generation backK212644 Aura StormInvictus Lighting · 2022
- This deviceK232642 AirKEE T900Healkee Medical Pte, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −6 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −5 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −4 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −3 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| −2 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| −1 | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
| 0 (this device) | K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K212644 | Aura StormSummary page 5…): Predicate Trade Name Aura Storm 510(k) Submitter / Holder Invictus Lighting 510(k) Number K212644 Regulation Number 21 CFR 880.6500 Classification Class II Classification Panel General… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K212644.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the filter of the subject device under the following exposure conditions: Test Item Avg. max Log Reduction/Entrainment Time (min) Room…
Read the full statement (157 words)
AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the filter of the subject device under the following exposure conditions:
Test Item Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test
Bacteria | Staphylococcus albus Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes (@ low fan speed
Bacteria | Escherichia coli Log 4 (99.99%)/60 minutes (@ high fan speed
Log 4 (99.99%)/120 minutes (@ low fan speed
Mold Penicillium rocqueforti Log 4 (99.99%)/60 minutes @ high fan speed
Mold Aspergillus Niger Log 4 (99.99%)/120 minutes (@ low fan speed
Virus Influenza A virus, HIN1 Log 4 (99.99%)/60 minutes (@ high fan speed
Virus Influenza A virus, H3N2 Log 4 (99.99%)/120 minutes @ low fan speed
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232642: AirKEE T900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232642
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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