AirKEE P900

K232933510(k) TraditionalCleared May 16, 2024239-day reviewClass II21 CFR 880.6500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Healkee Medical Pte, Ltd. · FRA Purifier, Air, Ultraviolet, Medical

Cleared on May 16, 2024 as substantially equivalent to K212644 (Invictus Lighting, 2022) after a 239-day review. Its family tree reaches back 7 generations to 2003.

Decided: May 16, 2024
Review: 239 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.

By dateBy generation

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 deviceK232933 AirKEE P900Healkee 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)	K232933	AirKEE P900	Healkee Medical Pte, Ltd.	2024	—

FIG. 1 — Lineage of K232933, 2003–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K212644	Aura Storm Summary 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…	Invictus Lighting	2022	—

Also cleared against K212644: 2 other devices →

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 devices

FRA 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

2007high 5 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRA

205in 2024

2007high 205 (2024) · low 175 (2022)2026

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

2007high 2 (2024) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	1
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	5	190	1
2022	4	175	1
2023	2	—	0
2024	4	205	2
2025	1	—	0
2026	0	—	—

What is it indicated for?

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…

Read the full statement (196 words)

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