510(k) · Cleared
ClearedMolekule Air Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molekule, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Aug 20, 2021 as substantially equivalent to K202339 (Molekule, Inc., 2021) after a 121-day review. Its family tree reaches back 6 generations to 2003. 3 later devices descend from it.
- Decided
- Aug 20, 2021
- Review
- 121 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K023830 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 5 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 4 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 3 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 2 generations backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- 1 generation backK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- This deviceK211194 Molekule Air ProMolekule, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213753 PurgoAeroclean Technologies, LLC · 2022
- Descendant · cites it directly · 0 of its ownK221540 Synexis Sphere RxSynexis, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK223328 PurgoAeroclean Technologies, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −5 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −4 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −3 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −2 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| −1 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| 0 (this device) | K211194 | Molekule Air Pro | Molekule, Inc. | 2021 | — |
| +1 | K213753 | Purgo | Aeroclean Technologies, LLC | 2022 | — |
| +1 | K221540 | Synexis Sphere Rx | Synexis, LLC | 2023 | — |
| +2 | K223328 | Purgo | Aeroclean Technologies, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K202339 | Molekule Air Mini, Molekule Air Mini +Summary page 4…ifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA PREDICATE DEVICE(S): Molekule Air Mini + Air Purifier, K202339 This predicate has not been subject to a design-related recall. Page 1 DE… | 2021 |
What descends from it? (3)
2 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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K213753 (Aeroclean Technologies, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K202339.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher.
The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211194: Molekule Air Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211194
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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