510(k) · Cleared
ClearedComfort Cough
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seoil Pacific Corp. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Feb 21, 2013 as substantially equivalent to K002598 (J. H. Emerson Co., 2000) and 1 other predicate after a 448-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 21, 2013
- Review
- 448 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002598 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 1…lass 11 Classification regulation: 21 CFR 868.5905 Product Code: NHJ 4. Predicate Device: Emerson Cough Assist by J.H. Emerson Co. (K002598) Pegaso Cough by Dima. Italia SRL (K072292) 510(k) Submission. 510(k)… | 2000 |
| * | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 PlusSummary page 1…68.5905 Product Code: NHJ 4. Predicate Device: Emerson Cough Assist by J.H. Emerson Co. (K002598) Pegaso Cough by Dima. Italia SRL (K072292) 510(k) Submission. 510(k) summary, 1 3 page 5. Description… | 2008 |
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 13 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- 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. 2013, 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?
For use on any patient 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 or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. *Clinical Settings: For use in a hospital / institutional environment, or in the home, given…
Read the full statement (122 words)
For use on any patient 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 or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube.
*Clinical Settings: For use in a hospital / institutional environment, or in the home, given adequate training and a physician's prescription.
*Patient Population: For use on children and adults. It should not be used on neonates and infants.
*Contraindications: Any patient with a history of bullous emphysema, known susceptibility to pneumnothorax or pneumomediastinum. or known to have any recent barotrauma, should be carefully considered before use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113549 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113549: Comfort Cough.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113549
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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