510(k) · Cleared
ClearedAirsonett Air-4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsonett AB · FRF Cleaner, Air, Medical Recirculating
Cleared on Jul 23, 2013 as substantially equivalent to K081062 (Airsonett, Inc., 2008) and 1 other predicate after a 130-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jul 23, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872359 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 |
|---|---|---|---|
| * | K081062 | Airsonnett Airshower Air 3Summary page 1…Class 11 21 CFR 880.5045 Product Code: FRF Equivalent Device Identification: Airsonett Airshower Air-3, K08 1062, BREATHE EASY (Models AD and CD) by RespirAid Ltd (K98 184 1) Device Description: Airsonett is based on the Temperature control… | 2008 |
| * | K981841 | Breathe Easy, Models AD and CDSummary page 1…Product Code: FRF Equivalent Device Identification: Airsonett Airshower Air-3, K08 1062, BREATHE EASY (Models AD and CD) by RespirAid Ltd (K98 184 1) Device Description: Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room e… | 1998 |
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 26 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- None of the 3 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. 2013, 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 Airsonett AJR-4 is a Mobile Mir Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130702: Airsonett Air-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130702
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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