510(k) · Cleared
ClearedTransformair Indoor Air Purifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transformair, LLC · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Feb 8, 2017 as substantially equivalent to K052732 (Abracair, Inc., 2006) after a 257-day review. Its family tree reaches back 3 generations to 2003. 14 later devices descend from it.
- Decided
- Feb 8, 2017
- Review
- 257 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023830 (2003). 14 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 2 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 1 generation backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- This deviceK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- Descendant · cites it directly · 11 of its ownK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- Descendant · 2 generations on · 9 of its ownK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK212644 Aura StormInvictus Lighting · 2022
- Descendant · 3 generations on · 3 of its ownK211194 Molekule Air ProMolekule, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK213753 PurgoAeroclean Technologies, LLC · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K200500Molekule Air Pro RXMolekule, Inc. · 2020 · cites it directly11descendants
- K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021 · 2 generations on9descendants
- K212644Aura StormInvictus Lighting · 2022 · 2 generations on3descendants
- K211194Molekule Air ProMolekule, Inc. · 2021 · 3 generations on3descendants
- K213753PurgoAeroclean Technologies, LLC · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −2 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −1 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| 0 (this device) | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| +1 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| +2 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| +2 | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
| +3 | K211194 | Molekule Air Pro | Molekule, Inc. | 2021 | — |
| +2 | K213753 | Purgo | Aeroclean Technologies, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
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 |
|---|---|---|---|
| * | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30PSummary page 5…ABRACAIR Air Cleaners QTZ300-‐60 and TI 100-‐30P Manufacturer Abracair, Inc. 510(k) Number K052732 Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet… | 2006 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200500 (Molekule, Inc., 2020) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161468: Transformair Indoor Air Purifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161468
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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