# K232642: AirKEE T900

- Pathway: 510(k) (Traditional)
- Applicant: Healkee Medical Pte, Ltd.
- Decided: May 23, 2024 after 267 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K023830 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212644: Aura Storm, Invictus Lighting (2022) Summary page 5.

## Indications for use
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

Source page: https://510kreport.com/device/K232642
Methodology: https://510kreport.com/methodology