# K120277: Vital Cough

- Pathway: 510(k) (Traditional)
- Applicant: Lung Assist, Inc.
- Decided: Sep 12, 2012 after 226 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: 1 generation back to K002598 (2000). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
2 of 8 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 2.

## Most influential descendants
- K132988: Vital Cough (2014), 5 descendants of its own
- 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

## Indications for use
The Vital Cough is intended for 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 a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

Source page: https://510kreport.com/device/K120277
Methodology: https://510kreport.com/methodology