510(k) · Cleared
ClearedSmartvest Airway Clearance System, Model TL
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 Dec 1, 2005 as substantially equivalent to K040367 (Electromed, Inc., 2004) after a 10-day review. Its family tree reaches back 3 generations to 1988. 5 later devices descend from it.
- Decided
- Dec 1, 2005
- Review
- 10 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884098 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 2 generations backK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
- 1 generation backK040367 Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004
- This deviceK053248 Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK122480 International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
- Descendant · cites it directly · 1 of its ownK132794 Smartvest Airway Clearance SystemElectromed, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK252849 AffloVest® Mobile Airway Clearance TherapyTactile Medical · 2026
- Descendant · 2 generations on · 0 of its ownK250860 BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK222496 Electromed SmartVest Airway Clearance SystemElectromed, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013 · cites it directly2descendants
- K132794Smartvest Airway Clearance SystemElectromed, Inc. · 2013 · cites it directly1descendant
- K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical · 2026 · 2 generations on0descendants
- K250860BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025 · 2 generations on0descendants
- K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −2 | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
| −1 | K040367 | Medpulse Respiratory Vest System, Model 2000EZ | Electromed, Inc. | 2004 | — |
| 0 (this device) | K053248 | Smartvest Airway Clearance System, Model TL | Electromed, Inc. | 2005 | — |
| +1 | K122480 | International Biophysics Corporation Afflovest | International Biophysics Corporation | 2013 | — |
| +1 | K132794 | Smartvest Airway Clearance System | Electromed, Inc. | 2013 | — |
| +2 | K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026 | — |
| +2 | K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025 | — |
| +2 | K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K040367 | Medpulse Respiratory Vest System, Model 2000EZSummary page 1…Model TL Classification: Powered Percussor, Class 1I Predicate Device: MedPulse® Respiratory Vest System, Model 2000 ez 510(K) number: K040367 Description of Device: The proposed SmartVest®' Airway Clearance System, Model TL is designed to deliver high-frequency chest w… | 2004 |
What descends from it? (5)
2 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 17 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122480 (International Biophysics Corporation, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Electromed SmartVest® Airway Clearance System, Model TL 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 as stated in the FDA summary.
https://510kreport.com/device/K053248 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053248: Smartvest Airway Clearance System, Model TL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053248
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