# K241140: ViroZap Indoor Air Purifier, In Duct Model 1008

- Pathway: 510(k) (Traditional)
- Applicant: Applied Photonix, LLC
- Decided: Aug 1, 2024 after 99 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 6.

## Indications for use
The ViroZapTM Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation. The ViroZapTM Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 – a non-enveloped ssRNA virus, Phi-X174 – a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions: Average Maximum Log Reduction / Exposure Time (hours) by Temperature Organism | Name | 45°F | 72°F | 110°F Bacteria | Staphylococcus epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours Bacterial endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours The ViroZapTM Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute): Average Net Log Reduction in 20 Minutes Organism | Name | Average Net Log Reduction in 20 Minutes Bacteria | Staphylococcus epidermidis | 5.17 Bacteria | Klebsiella aerogenes | 5.56 Virus | MS2 bacteriophage | 5.00 Virus | Phi-X174 bacteriophage | 5.34 Mold endospore | Aspergillus brasiliensis | 4.50 Bacterial endospore | Bacillus Subtilis | 4.58

Source page: https://510kreport.com/device/K241140
Methodology: https://510kreport.com/methodology