# K140605: Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug Perc

- Pathway: 510(k) (Traditional)
- Applicant: Dima Italia Srl
- Decided: Oct 3, 2014 after 207 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: 6 generations back to K884098 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 9.
- K072292: Negavent Plus Pegaso Cough, Model: DA-3 Plus, Dima Italia Srl (2008) Summary page 9.
- K121955: Coughassist T70 Device, Respironics, Inc. (2012) Summary page 10.
- K122111: Respironics Simplyclear Device, Respironics, Inc. (2012) Summary page 10.

## Indications for use
The MINI 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 MINI 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 MINI 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.

Source page: https://510kreport.com/device/K140605
Methodology: https://510kreport.com/methodology