510(k) · Cleared
Recalled · Class II · 2014Flutter (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bradstreet Clinical Research Assoc., Inc. · BYI Percussor, Powered-Electric
Cleared on Mar 13, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.
- Decided
- Mar 13, 1995
- Review
- 90 days
- Class
- Class II
- Product code
- BYI
- Recalls
- 1
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK946083 Flutter (R)Bradstreet Clinical Research Assoc., Inc. · 1995
- 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) | K946083 | Flutter (R) | Bradstreet Clinical Research Assoc., Inc. | 1995 | — |
| +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 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2014 | Class II | Z-1006-2015 | Process control | Customer notification that the device may be difficult to open or close. |
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/K946083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946083: Flutter (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946083
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026