510(k) · Cleared
ClearedBreatheBand® (Model 1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exemplar Medical, LLC · BYI Percussor, Powered-Electric
Cleared on Oct 2, 2025 as substantially equivalent to K122480 (International Biophysics Corporation, 2013) after a 195-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Oct 2, 2025
- Review
- 195 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884098 (1988). 6 ancestors in all. 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 backK122480 International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
- This deviceK250860 BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025
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 | K122480 | International Biophysics Corporation Afflovest | International Biophysics Corporation | 2013 | — |
| 0 (this device) | K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K122480 | International Biophysics Corporation AfflovestSummary page 6…devices under section 513 of the Act. Identification of the Predicate Device and Reference Device: Predicate Device: IBC AffloVest (K122480) Reference Device: Hill-Rom Monarch Airway Clearance System (K163378) Device Description: The BreatheBand® M… | 2013 |
| † | K163378 | Monarch Airway Clearance System | 2017 |
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 37 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K122480.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 BreatheBand® device is intended to deliver high-frequency chest wall oscillation (HFCWO) therapy to promote airway clearance and aid in general bronchial drainage when external chest manipulation or manipulation of the thorax is the physician's treatment of choice to enhance mucus transport.
It is indicated for adult patients (22 years of age and older) experiencing difficulty with secretion clearance.
The BreatheBand® device is intended for use in the home-care environment.
The BreatheBand® device is non-invasive, reusable, and intended for single-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250860: BreatheBand® (Model 1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250860
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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