510(k) · Cleared
ClearedFlutter (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varioraw SA · BYI Percussor, Powered-Electric
Cleared on May 24, 1994 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- May 24, 1994
- Review
- 84 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK940986 Flutter (R)Varioraw SA · 1994
- Descendant · cites it directly · 9 of its ownK972859 Flutter DBradstreet Clinical Research Assoc., Inc. · 1998
- Descendant · cites it directly · 5 of its ownK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · 2 generations on · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK203209 AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K972859Flutter DBradstreet Clinical Research Assoc., Inc. · 1998 · cites it directly9descendants
- K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999 · cites it directly5descendants
- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · 2 generations on3descendants
- K100749Frequencer Model V2XDymedso, Inc. · 2010 · 3 generations on2descendants
- K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940986 | Flutter (R) | Varioraw SA | 1994 | — |
| +1 | K972859 | Flutter D | Bradstreet Clinical Research Assoc., Inc. | 1998 | — |
| +1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +2 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +3 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +2 | K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 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?
- Of its descendants, K972859 (Bradstreet Clinical Research Assoc., Inc., 1998) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K940986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940986: Flutter (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940986
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026