510(k) · Cleared
ClearedVibralung Acoustical Percussor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westmed, Inc. · SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices
Cleared on May 23, 2014 as substantially equivalent to K063645 (Dymedso, Inc., 2007) and 5 other predicates after a 238-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- May 23, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- SDT
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K884098 (1988). 24 ancestors in all, the oldest K801982 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 6 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 5 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 4 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 3 generations backK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- 2 generations backK100749 Frequencer Model V2XDymedso, Inc. · 2010
- 1 generation backK103176 FrequencerDymedso, Inc. · 2011
- This deviceK133057 Vibralung Acoustical PercussorWestmed, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −6 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −5 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −4 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −3 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| −2 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| −1 | K103176 | Frequencer | Dymedso, Inc. | 2011 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 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 SDT? 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 SDT device
- #1 K241091 SIMEOX 200 Airway Clearance Devicescore 10.1 · 6 generations · no Class I recall
What was it cleared against? (6)
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…/Usual Name: Electric powered percussor Classification / CFR: BYI/CFR 868.5665 / Class 2 Device: Vibralung Acoustical Percussor Predicate Devices: Dymedso - Frequencer — K063645 and K103176 (Primary) DHD Healthcare (Smiths) — Acapella — K991561 and K002768 Medical Acoustics — Lung Flute ~ K091557 Device… | 2007 |
| * | K100749 | Frequencer Model V2XSummary page 3…Aerosol Contact Applied Technology Clearance delivery with airway During Frequencer X - - External Inhalation/ | Acoustical K063645 Chest wall | exhalation | power head K100749 applied to K103176 chest wall Acapella X X X Direct Exhalation | Interrupted K991561 Mouthpiece airflow at a K002768 frequency Lu… | 2010 |
| * | K103176 | FrequencerSummary page 1…Electric powered percussor Classification / CFR: BYI/CFR 868.5665 / Class 2 Device: Vibralung Acoustical Percussor Predicate Devices: Dymedso - Frequencer — K063645 and K103176 (Primary) DHD Healthcare (Smiths) — Acapella — K991561 and K002768 Medical Acoustics — Lung Flute ~ K091557 Device Description:… | 2011 |
| * | K991561 | Roadrunner, Pep Therapy DeviceSummary page 1…R 868.5665 / Class 2 Device: Vibralung Acoustical Percussor Predicate Devices: Dymedso - Frequencer — K063645 and K103176 (Primary) DHD Healthcare (Smiths) — Acapella — K991561 and K002768 Medical Acoustics — Lung Flute ~ K091557 Device Description: The proposed Vibralung Acoustical Percussor provides ai… | 1999 |
| * | K002768 | AcapellaSummary page 1…Class 2 Device: Vibralung Acoustical Percussor Predicate Devices: Dymedso - Frequencer — K063645 and K103176 (Primary) DHD Healthcare (Smiths) — Acapella — K991561 and K002768 Medical Acoustics — Lung Flute ~ K091557 Device Description: The proposed Vibralung Acoustical Percussor provides airway clearan… | 2000 |
| * | K091557 | Lung Flute TherapeuticSummary page 1…cussor Predicate Devices: Dymedso - Frequencer — K063645 and K103176 (Primary) DHD Healthcare (Smiths) — Acapella — K991561 and K002768 Medical Acoustics — Lung Flute ~ K091557 Device Description: The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K063645.
How does its category compare?
All SDT devicesSDT Intra-Pulmonary Percussive Vibration (Ipv) Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · SDT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SDT
Too few SDT 510(k)s in any year since 2007 to give a median.
Recalls per year · SDT
No recall names SDT since 2007.
Adverse event reports per year · SDT
No MAUDE report names SDT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.
Patient Population - Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems, patients with neuromuscular disease affecting the ability to effectively cough. Anyone who is able to read and / or follow verbal instructions
Environment of Use — Hospital and Home
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/K133057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133057: Vibralung Acoustical Percussor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133057
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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