510(k) · Cleared
ClearedKT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Ruijiong Biotech Co., Ltd. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Jun 16, 2026 as substantially equivalent to K140598 (Dima Italia Srl, 2014) after a 270-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jun 16, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K884098 (1988). 10 ancestors in all. 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 backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 2 generations backK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- 1 generation backK140598 Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014
- This deviceK253001 KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II…Hunan Ruijiong Biotech Co., Ltd. · 2026
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 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −2 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| −1 | K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc | Dima Italia Srl | 2014 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercSummary page 5…e, Positive Pressure Breathing, Intermittent Regulation Number: 868.5905 Class II Product Code(s): NHJ Primary Predicate Device(s) Dima Italia Srl PEGASO A-COUGH PERC (K140598) Reference Device(s) Breas Medical AB Clearo (K242438) Device Description Summary The KT Airway Clearance Device II is an activ… | 2014 |
| † | K242438 | Clearo | 2025 |
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 38 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
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. 2026, 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 KT Airway Clearance Device II is designed for the use on patients unable to cough or clear secretions effectively by applying a positive pressure to the airway, then rapidly shifting to a negative pressure, or providing high frequency oscillatory vibrations.
The device 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.
For use on adult or pediatric patients 3 years of age and older who have difficulty with secretion clearance and/or inability to cough.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253001: KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253001
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026