510(k) · Cleared
ClearedAirsonnett Airshower Air 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsonett, Inc. · FRF Cleaner, Air, Medical Recirculating
Cleared on Nov 7, 2008 as substantially equivalent to K981841 (Respiraid, Ltd., 1998) after a 207-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Nov 7, 2008
- Review
- 207 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872359 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872359 Enviracaire Model EV-1Enviracaire Corp. · 1987
- 1 generation backK981841 Breathe Easy, Models AD and CDRespiraid, Ltd. · 1998
- This deviceK081062 Airsonnett Airshower Air 3Airsonett, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK130702 Airsonett Air-4Airsonett AB · 2013
Most influential descendants
Showing 1 of 1 · See all- K130702Airsonett Air-4Airsonett AB · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872359 | Enviracaire Model EV-1 | Enviracaire Corp. | 1987 | — |
| −1 | K981841 | Breathe Easy, Models AD and CD | Respiraid, Ltd. | 1998 | — |
| 0 (this device) | K081062 | Airsonnett Airshower Air 3 | Airsonett, Inc. | 2008 | — |
| +1 | K130702 | Airsonett Air-4 | Airsonett AB | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K981841 | Breathe Easy, Models AD and CDSummary page 1…er Device Name and Classification: Sec. 880.5045 Medical Recirculating Air Cleaner. Equivalent Device Identification: BREATHE EASY (Models AD and CD) by RespirAid Ltd (K98 1841) Device Description: The Airsonett Airshower Air 3 Mobile Medical Air Cleaner is an adjustable, portable, personal system for us… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130702 | Airsonett Air-4 | 2013 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130702 (Airsonett AB, 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K981841.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Airshower Air 3 is a Mobile Air 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/K081062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081062: Airsonnett Airshower Air 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081062
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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