510(k) · Cleared
ClearedInternational Biophysics Corporation Afflovest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corporation · BYI Percussor, Powered-Electric
Cleared on Mar 27, 2013 as substantially equivalent to K965192 (American Biosystems, Inc., 1997) and 1 other predicate after a 225-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- Mar 27, 2013
- Review
- 225 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K884098 (1988). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 3 generations backK982889 Medpulse Respiratory Vest System, Model 1000Electromed, Inc. · 1999
- 2 generations backK040367 Medpulse Respiratory Vest System, Model 2000EZElectromed, Inc. · 2004
- 1 generation backK053248 Smartvest Airway Clearance System, Model TLElectromed, Inc. · 2005
- This deviceK122480 International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
- Descendant · cites it directly · 0 of its ownK252849 AffloVest® Mobile Airway Clearance TherapyTactile Medical · 2026
- Descendant · cites it directly · 0 of its ownK250860 BreatheBand® (Model 1000)Exemplar Medical, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −3 | K982889 | Medpulse Respiratory Vest System, Model 1000 | Electromed, Inc. | 1999 | — |
| −2 | K040367 | Medpulse Respiratory Vest System, Model 2000EZ | Electromed, Inc. | 2004 | — |
| −1 | K053248 | Smartvest Airway Clearance System, Model TL | Electromed, Inc. | 2005 | — |
| 0 (this device) | K122480 | International Biophysics Corporation Afflovest | International Biophysics Corporation | 2013 | — |
| +1 | K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026 | — |
| +1 | K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K965192 | Thairapy Vest SystemSummary page 1…eutic Device, Powered Percussor 73-BYI 21 CFR 868.5665 Legally Marketed Predicate K965192 - Hill-Rom Device The Vest® Airway Clearance System by Hill-Rom is… | 1997 |
| * | K053248 | Smartvest Airway Clearance System, Model TLSummary page 2…smaller to larger airways, it can be easily removed by coughing or suctioning. K053248 - Electromed Inc. The SmartVest®' Airway Clearance System, Model TL. is… | 2005 |
What descends from it? (2)
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 25 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K252849 (Tactile Medical, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K965192.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 International Biophysics Corporation AffioVest is intended for promoting airway clearance and Improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax Is the physician's choice of treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122480: International Biophysics Corporation Afflovest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122480
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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