510(k) · Cleared
ClearedCUBE Air Purifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Nov 26, 2021 as substantially equivalent to K161468 (Transformair, LLC, 2017) after a 224-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Nov 26, 2021
- Review
- 224 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 deviceK211139 CUBE Air PurifierSamsung Electronics Co., Ltd. · 2021
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) | K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | 2021 | — |
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 4…roduct Code: FRA • Panel: General Hospital • Regulation Number: 21 CFR §880.6500 • Device Class: Class II • Date prepared: 10/14/2021 Predicate Device Primary Predicate K161468, Transformair Indoor Air Purifier by Transformair, LLC. Reference Device K200500, Molekule Air Pro RX by Molekule, Inc. Indicat… | 2017 |
| † | K200500 | Molekule Air Pro RX | 2020 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.8 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. 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 CUBE Air Purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. The CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli entrained on the filter of the subject device under the following exposure conditions: Organisms — Name — Average Maximum log…
Read the full statement (104 words)
The CUBE Air Purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.
The CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli entrained on the filter of the subject device under the following exposure conditions:
Organisms — Name — Average Maximum log reduction/exposure time (hours), Room temperature test
Virus — MS2 bacteriophage — 5.33±0.23 /60 mins
Virus — Phi-X174 bacteriophage — 5.34±0.11 /60 mins
Bacteria — Staphylococcus epidermidis — 5.36±0.28 /60 mins
Bacteria — Escherichia coli — 5.17±0.05 /60 mins
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211139: CUBE 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/K211139
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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