510(k) · Cleared
ClearedPegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dima Italia Srl · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Oct 16, 2014 as substantially equivalent to K002598 (J. H. Emerson Co., 2000) and 3 other predicates after a 220-day review. Its family tree reaches back 6 generations to 1988. 1 later device descends from it.
- Decided
- Oct 16, 2014
- Review
- 220 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K884098 (1988). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 5 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 4 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 3 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 2 generations backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 1 generation backK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- This deviceK140598 Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014
- Descendant · cites it directly · 0 of its ownK253001 KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II…Hunan Ruijiong Biotech Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −5 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −4 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −3 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −2 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −1 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| 0 (this device) | K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc | Dima Italia Srl | 2014 | — |
| +1 | K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 NHJ? 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 NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingSummary page 10…b) Classification. Class II (performance standards) Predicate device Name(s) and Emerson Cough Assist, Model CA-3000 K002598 510(k) numbers: Dima Italia Negavent DA-3 Plus Pegaso K072292… | 2000 |
| * | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 PlusSummary page 10…Name(s) and Emerson Cough Assist, Model CA-3000 K002598 510(k) numbers: Dima Italia Negavent DA-3 Plus Pegaso K072292 Philips Respironics CoughAssist T70 K121955… | 2008 |
| * | K121955 | Coughassist T70 DeviceSummary page 10…Dima Italia Negavent DA-3 Plus Pegaso K072292 Philips Respironics CoughAssist T70 K121955 Respironics SimplyClear Percussor K122111 Reason for submission… | 2012 |
| * | K122111 | Respironics Simplyclear DeviceSummary page 10…Philips Respironics CoughAssist T70 K121955 Respironics SimplyClear Percussor K122111 Reason for submission Device modification. Description of device. The Dima Italia Srl Pegaso Cough is an… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | 2026 | 0 |
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 2.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K253001 (Hunan Ruijiong Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K002598.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, 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 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
The PEGASO A-COUGH PERC is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient’s endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given…
Read the full statement (256 words)
The PEGASO A-COUGH PERC is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient’s endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
The PEGASO A-COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient’s endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
The PEGASO COUGH is designed for the use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient’s endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training.
For use on adult patients and pediatric patients 3 years old and up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140598: Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140598
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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