510(k) · Cleared
ClearedFlutter D
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 Jun 5, 1998 as substantially equivalent to K940986 (Varioraw SA, 1994) and 1 other predicate after a 305-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.
- Decided
- Jun 5, 1998
- Review
- 305 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940986 (1994). 2 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK940986 Flutter (R)Varioraw SA · 1994
- This deviceK972859 Flutter DBradstreet Clinical Research Assoc., Inc. · 1998
- Descendant · cites it directly · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK203209 AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK140772 Aerosure MedicActegy, Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK103176 FrequencerDymedso, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · cites it directly3descendants
- K100749Frequencer Model V2XDymedso, Inc. · 2010 · 2 generations on2descendants
- K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd. · 2021 · cites it directly1descendant
- K140772Aerosure MedicActegy, Ltd. · 2014 · cites it directly1descendant
- K103176FrequencerDymedso, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940986 | Flutter (R) | Varioraw SA | 1994 | — |
| 0 (this device) | K972859 | Flutter D | Bradstreet Clinical Research Assoc., Inc. | 1998 | — |
| +1 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +2 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +1 | K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021 | — |
| +1 | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| +3 | K103176 | Frequencer | Dymedso, Inc. | 2011 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K940986 | Flutter (R)Summary page 1…Research Associates, Inc. 1588 Route 130 North, Suite C-2 ' North Brunswick, NJ 08902 (732) 821-0800 Flutter® Mucus Clearance Device which was cleared for market under K940986 and K946083. The Flutter®D is a small hand held device consisting of a hardened plastic mouthpiece at one end, a plastic cover w… | 1994 |
| * | K946083 | Flutter (R)Summary page 1…ociates, Inc. 1588 Route 130 North, Suite C-2 ' North Brunswick, NJ 08902 (732) 821-0800 Flutter® Mucus Clearance Device which was cleared for market under K940986 and K946083. The Flutter®D is a small hand held device consisting of a hardened plastic mouthpiece at one end, a plastic cover with an openi… | 1995 |
What descends from it? (9)
4 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?
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 | — |
What is it indicated for?
The efficacy of the Flutter®D as a mucus clearance device for cystic fibrosis patients is based on its ability to 1) vibrate the airways (which loosens mucus from the airway walls), 2) intermittently increase endobronchial pressure (to maintain the patency of airways during exhalation, so that mucus does not become trapped as it moves up the airways), and 3) accelerate expiratory airflow (to facilitate the upward movement of mucus through the airways so…
Read the full statement (115 words)
The efficacy of the Flutter®D as a mucus clearance device for cystic fibrosis patients is based on its ability to 1) vibrate the airways (which loosens mucus from the airway walls), 2) intermittently increase endobronchial pressure (to maintain the patency of airways during exhalation, so that mucus does not become trapped as it moves up the airways), and 3) accelerate expiratory airflow (to facilitate the upward movement of mucus through the airways so that it can be more easily coughed out). Flutter®D may also be useful in the removal of mucus from the lungs of 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/K972859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972859: Flutter D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972859
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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