510(k) · Cleared
ClearedMedpulse Respiratory Vest System, Model 1000
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 Jun 1, 1999 as substantially equivalent to K884098 (American Biosystems, Inc., 1988) after a 288-day review. Its family tree reaches back 1 generation to 1988. 11 later devices descend from it.
- Decided
- Jun 1, 1999
- Review
- 288 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884098 (1988). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- This deviceK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK040367 Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK053248 Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK122480 International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
- Descendant · 2 generations on · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040367Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004 · cites it directly6descendants
- K053248Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005 · 2 generations on5descendants
- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · cites it directly3descendants
- K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013 · 3 generations on2descendants
- K100749Frequencer Model V2XDymedso, Inc. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| 0 (this device) | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
| +1 | K040367 | Medpulse Respiratory Vest System, Model 2000EZ | Electromed, Inc. | 2004 | — |
| +2 | K053248 | Smartvest Airway Clearance System, Model TL | Electromed, Inc. | 2005 | — |
| +1 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +3 | K122480 | International Biophysics Corporation Afflovest | International Biophysics Corporation | 2013 | — |
| +2 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101Summary page 1…RespiratoryVest System Common Name: Powered Percussor Classification: Powered Percussor-Electric (21 CFR 868.5665) Class I1 Predicate Device: ThAIRapyR Vest System, #K884098 Description of Device: The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid i… | 1988 |
What descends from it? (11)
See all 112 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?
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™ RespiratoryVest System is designed specifically to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest 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/K982889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982889: Medpulse Respiratory Vest System, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982889
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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