510(k) · Cleared
ClearedAirPhysio Positive Expiratory Pressure (PEP) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airphysio Pty, Ltd. · BYI Percussor, Powered-Electric
Cleared on Jan 15, 2021 as substantially equivalent to K972859 (Bradstreet Clinical Research Assoc., Inc., 1998) after a 77-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 15, 2021
- Review
- 77 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940986 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK940986 Flutter (R)Varioraw SA · 1994
- 1 generation backK972859 Flutter DBradstreet Clinical Research Assoc., Inc. · 1998
- This deviceK203209 AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK241091 SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940986 | Flutter (R) | Varioraw SA | 1994 | — |
| −1 | K972859 | Flutter D | Bradstreet Clinical Research Assoc., Inc. | 1998 | — |
| 0 (this device) | K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021 | — |
| +1 | K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K972859 | Flutter DSummary page 4…owered Percussor Regulation Number: 21 CFR 868.5665, Class II Product Code: BYI Predicate Device: Flutter D – Clement Clarke – K972859 Device Description: AirPhysio is a small, handheld expiration resistance device, consisting of a hardened plastic mouthpiece at… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance Device | 2024 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K241091 (Inogen, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972859.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways.
AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.
The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.
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/K203209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203209: AirPhysio Positive Expiratory Pressure (PEP) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203209
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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