510(k) · Cleared
ClearedFrequencer, Model 1001
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 Mar 15, 2007 as substantially equivalent to K965192 (American Biosystems, Inc., 1997) and 4 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1988. 3 later devices descend from it.
- Decided
- Mar 15, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K884098 (1988). 14 ancestors in all, the oldest K801982 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 3 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 2 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 1 generation backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- This deviceK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK103176 FrequencerDymedso, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK133057 Vibralung Acoustical PercussorWestmed, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −3 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −2 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −1 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| 0 (this device) | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +1 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K965192 | Thairapy Vest SystemSummary page 1…ered Percussor Classification Name: Percussor, Powered-Electric Device Class: 2 Product Code: BYI Predicate Devices: K9651 92-Thairapy® Vest System, K972859-Flutter® 0 Mucus Clearance Device, K982889-Medpulse TM Respiratory Vest System, Model 1000, K01292… | 1997 |
| * | K972859 | Flutter DSummary page 1…me: Percussor, Powered-Electric Device Class: 2 Product Code: BYI Predicate Devices: K9651 92-Thairapy® Vest System, K972859-Flutter® 0 Mucus Clearance Device, K982889-Medpulse TM Respiratory Vest System, Model 1000, K012928-AbiVeSt TM Airway Clearance S… | 1998 |
| * | K982889 | Medpulse Respiratory Vest System, Model 1000Summary page 1…c Device Class: 2 Product Code: BYI Predicate Devices: K9651 92-Thairapy® Vest System, K972859-Flutter® 0 Mucus Clearance Device, K982889-Medpulse TM Respiratory Vest System, Model 1000, K012928-AbiVeSt TM Airway Clearance System, K972859-Flutter® D Mucus Clearance D… | 1999 |
| * | K012928 | Abi Vest Airway Clearance SystemSummary page 1…BYI Predicate Devices: K9651 92-Thairapy® Vest System, K972859-Flutter® 0 Mucus Clearance Device, K982889-Medpulse TM Respiratory Vest System, Model 1000, K012928-AbiVeSt TM Airway Clearance System, K972859-Flutter® D Mucus Clearance Device K031876-Electro Flo Percussor, Model 5000 Descript… | 2001 |
| * | K031876 | Electro Flo Percussor, Model 5000Summary page 1…0 Mucus Clearance Device, K982889-Medpulse TM Respiratory Vest System, Model 1000, K012928-AbiVeSt TM Airway Clearance System, K972859-Flutter® D Mucus Clearance Device K031876-Electro Flo Percussor, Model 5000 Description: The Frequencer TM provides airway clearance therapy and promotes bronchial draina… | 2003 |
What descends from it? (3)
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 19 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K100749 (Dymedso, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K965192.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 FrequencerTM provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy 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 (142 words)
The FrequencerTM provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063645: Frequencer, Model 1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063645
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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