# K113549: Comfort Cough

- Pathway: 510(k) (Traditional)
- Applicant: Seoil Pacific Corp.
- Decided: Feb 21, 2013 after 448 days
- Product code: NHJ (Device, Positive Pressure Breathing, Intermittent)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002598 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002598: Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual Timing, J. H. Emerson Co. (2000) Summary page 1.
- K072292: Negavent Plus Pegaso Cough, Model: DA-3 Plus, Dima Italia Srl (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K113549
Methodology: https://510kreport.com/methodology