# K132988: Vital Cough

- Pathway: 510(k) (Traditional)
- Applicant: Lung Assist, Inc.
- Decided: Mar 28, 2014 after 185 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). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120277: Vital Cough, Lung Assist, Inc. (2012) Summary page 2.
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 2.

## Most influential descendants
- K192143: Maximus System (2020), 4 descendants of its own
- K200988: Maximus System (2020), 3 descendants of its own
- K231728: BiWaze Clear System (2024), 1 descendant of its own
- K260604: BiWaze Clear System (2026), 0 descendants of its own
- K213564: BiWaze Clear System (2022), 0 descendants of its own

## Indications for use
The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to rcduced peak cough expiratory flaw resulting fronm high spinal cord injuries, neuromuscular deficits or severe fatigue associated wit intrinsic lung disease. It may be used either with a facemask. mouthpiece, or an adapter to a patient's codotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

Source page: https://510kreport.com/device/K132988
Methodology: https://510kreport.com/methodology