510(k) · Cleared
ClearedPlasmair, Model T2006
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airinspace B.V. · FRF Cleaner, Air, Medical Recirculating
Cleared on Dec 14, 2007 as substantially equivalent to K972064 (Biological Controls, Inc., 1997) after a 274-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 274 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972064 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
- This deviceK070722 Plasmair, Model T2006Airinspace B.V. · 2007
- Descendant · cites it directly · 5 of its ownK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK220298 CerroZone MobileCerrozone · 2022
- Descendant · 3 generations on · 0 of its ownK242102 CerroZone MiniCerrozone, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK240696 Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200321Novaerus NV1050Novaerus Us, Inc. · 2020 · cites it directly5descendants
- K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022 · 2 generations on1descendant
- K220298CerroZone MobileCerrozone · 2022 · 2 generations on1descendant
- K242102CerroZone MiniCerrozone, LLC · 2024 · 3 generations on0descendants
- K240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv | Biological Controls, Inc. | 1997 | — |
| 0 (this device) | K070722 | Plasmair, Model T2006 | Airinspace B.V. | 2007 | — |
| +1 | K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020 | — |
| +2 | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech, Ltd. | 2022 | — |
| +2 | K220298 | CerroZone Mobile | Cerrozone | 2022 | — |
| +3 | K242102 | CerroZone Mini | Cerrozone, LLC | 2024 | — |
| +3 | K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 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 FRF? 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 FRF device
- #1 K200321 Novaerus NV1050score 9.9 · 2 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 |
|---|---|---|---|
| * | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvSummary page 1…ices previously cleared through the 510(k) process. Substantial Equivalence The new device is substantially equivalent to the Biological Controls, Inc, MICROCON 800MUV (K972064). Technological Characteristics The device uses spatially modulated, amplified multidirectional electrostatic field technology t… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200321 | Novaerus NV1050 | 2020 | 5 |
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?
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FRF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRF
163in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRF
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRF
3in 2013
MAUDE reports naming product code FRF, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 163 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Plasmair Model T2006 is intended as a room air purifier/recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Plasmair T2006 is designed to treat indoor air to supplement existing building air treatment and/or provide air treatment where none exists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070722: Plasmair, Model T2006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070722
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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