# K161468: Transformair Indoor Air Purifier

- Pathway: 510(k) (Traditional)
- Applicant: Transformair, LLC
- Decided: Feb 8, 2017 after 257 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: 3 generations back to K023830 (2003). 3 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052732: Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P, Abracair, Inc. (2006) Summary page 5.

## Most influential descendants
- K200500: Molekule Air Pro RX (2020), 11 descendants of its own
- K202339: Molekule Air Mini, Molekule Air Mini + (2021), 9 descendants of its own
- K212644: Aura Storm (2022), 3 descendants of its own
- K211194: Molekule Air Pro (2021), 3 descendants of its own
- K213753: Purgo (2022), 1 descendant of its own

## Indications for use
The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:

Source page: https://510kreport.com/device/K161468
Methodology: https://510kreport.com/methodology