# K072290: Pegaso V, Negavent Respirator, Model: DA-3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dima Italia Srl
- Decided: May 29, 2008 after 287 days
- Product code: BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass))
- Device class: 2
- Regulation: 21 CFR 868.5935
- 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 K910947 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910947: Nev-10 Negative Pressure Ventilator, Lifecare Services, Inc. (1991) Summary page 1.

## Indications for use
The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or ventilating chamber (Porta-Lung).

Source page: https://510kreport.com/device/K072290
Methodology: https://510kreport.com/methodology