510(k) · Cleared
ClearedMedpulse Respiratory Vest System, Model 2000EZ
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 Apr 7, 2004 as substantially equivalent to K982889 (Electromed, Inc., 1999) after a 54-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it.
- Decided
- Apr 7, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884098 (1988). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 1 generation backK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
- This deviceK040367 Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK053248 Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK122480 International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK132794 Smartvest Airway Clearance SystemElectromed, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK252849 AffloVest® Mobile Airway Clearance TherapyTactile Medical · 2026
- Descendant · 3 generations on · 0 of its ownK250860 BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K053248Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005 · cites it directly5descendants
- K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013 · 2 generations on2descendants
- K132794Smartvest Airway Clearance SystemElectromed, Inc. · 2013 · 2 generations on1descendant
- K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical · 2026 · 3 generations on0descendants
- K250860BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −1 | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
| 0 (this device) | K040367 | Medpulse Respiratory Vest System, Model 2000EZ | Electromed, Inc. | 2004 | — |
| +1 | K053248 | Smartvest Airway Clearance System, Model TL | Electromed, Inc. | 2005 | — |
| +2 | K122480 | International Biophysics Corporation Afflovest | International Biophysics Corporation | 2013 | — |
| +2 | K132794 | Smartvest Airway Clearance System | Electromed, Inc. | 2013 | — |
| +3 | K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026 | — |
| +3 | K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K982889 | Medpulse Respiratory Vest System, Model 1000Summary page 1…ussor, Class II Predicate Device: MedPulse® Respiratory Vest System Model 2000 510(K) number: K982889 Description of Device: The proposed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053248 | Smartvest Airway Clearance System, Model TL | 2005 | 5 |
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 16 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K053248 (Electromed, Inc., 2005) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K982889.
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 MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® 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/K040367 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040367: Medpulse Respiratory Vest System, Model 2000EZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040367
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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