# K232933: AirKEE P900

- Pathway: 510(k) (Traditional)
- Applicant: Healkee Medical Pte, Ltd.
- Decided: May 16, 2024 after 239 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 P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE P900 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) (in a 20m3 chamber) Bacteria Staphylococcus aureus 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 Bacteria Klebsiella pneumoniae Log 4 (99.99%)/60 minutes@ high fan speed Log 4 (99.99%)/120 minutes@ low fan speed Bacteria Pseudomonas aeruginosa Log 4 (99.99%)/60 minutes@ high fan speed Log 4 (99.99%)/120 minutes@ low fan speed Bacteria Ser:ratia marcescens Log 4 (99.99%)/60 minutes@ high fan speed Log 4 (99.99%)/120 minutes@ low fan speed Mold Aspergillus Niger Log 4 (99.99%)/60 minutes@ high fan speed Log 4 (99.99%)/120 minutes@ low fan speed Virus Influenza A virus, RINI Log 4 (99.99%)/60 minutes@ high fan speed Virus Influenza A virus, H3N3 Log 4 (99.99%)/120 minutes@ low fan speed

Source page: https://510kreport.com/device/K232933
Methodology: https://510kreport.com/methodology