510(k) · Cleared
ClearedElectromed SmartVest Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electromed, Inc. · BYI Percussor, Powered-Electric
Cleared on Nov 18, 2022 as substantially equivalent to K132794 (Electromed, Inc., 2013) after a 92-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Nov 18, 2022
- Review
- 92 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884098 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 4 generations backK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
- 3 generations backK040367 Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004
- 2 generations backK053248 Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005
- 1 generation backK132794 Smartvest Airway Clearance SystemElectromed, Inc. · 2013
- This deviceK222496 Electromed SmartVest Airway Clearance SystemElectromed, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −4 | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
| −3 | K040367 | Medpulse Respiratory Vest System, Model 2000EZ | Electromed, Inc. | 2004 | — |
| −2 | K053248 | Smartvest Airway Clearance System, Model TL | Electromed, Inc. | 2005 | — |
| −1 | K132794 | Smartvest Airway Clearance System | Electromed, Inc. | 2013 | — |
| 0 (this device) | K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022 | — |
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 BYI? 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 BYI device
- #1 K252849 AffloVest® Mobile Airway Clearance Therapyscore 12.5 · 5 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 |
|---|---|---|---|
| * | K132794 | Smartvest Airway Clearance SystemSummary page 4…8.5665, Powered percussor Product Code: BYI Class: II Panel: Anesthesiology PREDICATE DEVICE SmartVest® Airway Clearance System, Model SQL; K132794 INDICATIONS FOR USE The Indications for Use of the proposed modified device are identical to the legally marketed… | 2013 |
| † | K142482 | The Vest Airway Clearance System | 2015 |
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 34 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · BYI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BYI
157in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYI
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BYI
38in 2025
MAUDE reports naming product code BYI, 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 | 8 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 3 | 225 | 0 | 6 |
| 2014 | 0 | — | 1 | 10 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 1 | 4 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 3 | 157 | 0 | 19 |
| 2025 | 1 | — | 0 | 38 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SmartVest® Airway Clearance System, Model Clearway is designed to deliver high frequency chest wall oscillation
to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest
manipulation is the physician’s treatment of choice to enhance mucus transport.
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/K222496 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222496: Electromed SmartVest Airway Clearance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222496
Report an extraction error
Are you the manufacturer?
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