# K211139: CUBE Air Purifier

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Nov 26, 2021 after 224 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: 4 generations back to K023830 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161468: Transformair Indoor Air Purifier, Transformair, LLC (2017) Summary page 4.

## Indications for use
The CUBE Air Purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. The CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli entrained on the filter of the subject device under the following exposure conditions: Organisms — Name — Average Maximum log reduction/exposure time (hours), Room temperature test Virus — MS2 bacteriophage — 5.33±0.23 /60 mins Virus — Phi-X174 bacteriophage — 5.34±0.11 /60 mins Bacteria — Staphylococcus epidermidis — 5.36±0.28 /60 mins Bacteria — Escherichia coli — 5.17±0.05 /60 mins

Source page: https://510kreport.com/device/K211139
Methodology: https://510kreport.com/methodology