510(k) · Cleared
ClearedViroZap Indoor Air Purifier, In Duct Model 1008
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Photonix, LLC · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Aug 1, 2024 as substantially equivalent to K161468 (Transformair, LLC, 2017) after a 99-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Aug 1, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K023830 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 3 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 2 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 1 generation backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- This deviceK241140 ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −3 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −2 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −1 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| 0 (this device) | K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | 2024 | — |
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
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 | Decided |
|---|---|---|---|
| * | K161468 | Transformair Indoor Air PurifierSummary page 6…wn in the following table: Predicate Device Transformair Indoor Air Purifier Manufacturer Transformair, Inc. 510(k) Number K161468 Regulation Number 21 C.F.R. § 880.6500 Regulation Name Medical Ultraviolet Air Purifier Regulatory Cl… | 2017 |
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 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K161468.
How does its category compare?
All FRA devicesFRA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (324 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241140: ViroZap Indoor Air Purifier, In Duct Model 1008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241140
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026