510(k) · Cleared
ClearedFrequencer Model V2X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dymedso, Inc. · BYI Percussor, Powered-Electric
Cleared on Aug 31, 2010 as substantially equivalent to K063645 (Dymedso, Inc., 2007) after a 168-day review. Its family tree reaches back 5 generations to 1988. 2 later devices descend from it.
- Decided
- Aug 31, 2010
- Review
- 168 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884098 (1988). 15 ancestors in all, the oldest K801982 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 4 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 3 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 2 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 1 generation backK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- This deviceK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103176 FrequencerDymedso, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK133057 Vibralung Acoustical PercussorWestmed, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −5 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −4 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −3 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −2 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −1 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| 0 (this device) | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +1 | K103176 | Frequencer | Dymedso, Inc. | 2011 | — |
| +1 | K133057 | Vibralung Acoustical Percussor | Westmed, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K063645 | Frequencer, Model 1001Summary page 1…Device Classification Name: Percussor, Powered-Electric Device Class: 2 Product Code: BYI Predicate Device: K063645 - Frequencer T M 1001 Description: The Frequencer T M v2x provides airway clearance therapy and promotes bronchial drainage by i… | 2007 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K103176 (Dymedso, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063645.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Frequencer TM v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis…
Read the full statement (155 words)
The Frequencer TM v2x provides airway clearance therapy and promotes
bronchial drainage by inducing vibration in the chest walls. This device is
intended to be a component of chest physiotherapy by providing a convenient
method of external thorax manipulation.
It is indicated for patients having respiratory ailments which involve defective
mucociliary clearance, as is typical in patients suffering from cystic fibrosis as
well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma,
muscular dystrophy, neuromuscular degenerative disorders, post-operative
atelectasis and thoracic wall defects. Indications for this form of therapy are
described in the Clinical Practice Guidelines for Postural Drainage Therapy of the
American Association for Respiratory Care (AARC) published in 1991. This
particular device provides a gentler, less painful form of therapy than the
traditional "clapping" method of postural drainage therapy, allowing it to be used
on patients who cannot be treated by clapping.
The Frequencer~m v2x is only intended for use in hospitals and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100749: Frequencer Model V2X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100749
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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