510(k) · Cleared
ClearedNovaerus NV1050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novaerus Us, Inc. · FRF Cleaner, Air, Medical Recirculating
Cleared on Dec 28, 2020 as substantially equivalent to K070722 (Airinspace B.V., 2007) after a 322-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 28, 2020
- Review
- 322 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972064 (1997). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
- 1 generation backK070722 Plasmair, Model T2006Airinspace B.V. · 2007
- This deviceK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK220298 CerroZone MobileCerrozone · 2022
- Descendant · 2 generations on · 0 of its ownK242102 CerroZone MiniCerrozone, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK240696 Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220990 Qorda QD1Winix, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022 · cites it directly1descendant
- K220298CerroZone MobileCerrozone · 2022 · cites it directly1descendant
- K242102CerroZone MiniCerrozone, LLC · 2024 · 2 generations on0descendants
- K240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K220990Qorda QD1Winix, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv | Biological Controls, Inc. | 1997 | — |
| −1 | K070722 | Plasmair, Model T2006 | Airinspace B.V. | 2007 | — |
| 0 (this device) | K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020 | — |
| +1 | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech, Ltd. | 2022 | — |
| +1 | K220298 | CerroZone Mobile | Cerrozone | 2022 | — |
| +2 | K242102 | CerroZone Mini | Cerrozone, LLC | 2024 | — |
| +2 | K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024 | — |
| +1 | K220990 | Qorda QD1 | Winix, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K242102 CerroZone Miniscore 9.3 · 4 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 |
|---|---|---|---|
| * | K070722 | Plasmair, Model T2006Summary page 4…t Code/CFR Reference Medical recirculating air cleaner, Product Code: FRF CFR Reference: 21 CFR 880.5045 3. PREDICATE DEVICE Predicate: Plasmair Model T2006 [K070722], Commercial name: Sentinel This predicate has not been subject to a design-related recall No reference devices were used in… | 2007 |
What descends from it? (5)
3 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 23 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211507 (Beiang Air Tech, Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and
inactivating airborne particles from the air for medical purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200321 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200321: Novaerus NV1050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200321
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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