510(k) · Cleared
ClearedAirdog X8 Air Purifier (KJ800F-X8)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Beiang Smart Technology Co., Ltd. · FRF Cleaner, Air, Medical Recirculating
Cleared on Jun 14, 2024 as substantially equivalent to K211507 (Beiang Air Tech, Ltd., 2022) after a 92-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jun 14, 2024
- Review
- 92 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972064 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
- 3 generations backK070722 Plasmair, Model T2006Airinspace B.V. · 2007
- 2 generations backK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
- 1 generation backK211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022
- This deviceK240696 Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv | Biological Controls, Inc. | 1997 | — |
| −3 | K070722 | Plasmair, Model T2006 | Airinspace B.V. | 2007 | — |
| −2 | K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020 | — |
| −1 | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech, Ltd. | 2022 | — |
| 0 (this device) | K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Summary page 6…inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed. Predicate Device(s) K211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)/ BeiAng Air Tec… | 2022 |
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 27 years and passes through 5 companies; a new generation was cleared every 10.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Airdog X8 Air Purifier is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240696: Airdog X8 Air Purifier (KJ800F-X8).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240696
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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