# K031470: Puritan Bennett, Goodknight 420 Evolution, Model M-113903-US

- Pathway: 510(k) (Special)
- Applicant: Tyco Healthcare Nancy
- Decided: Jun 5, 2003 after 27 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- 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: 5 generations back to K903764 (1990). 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)
- K020886: Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S Model M-113903-US, Tyco Healthcare Nancy (2002)
- K993584: Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2, Nellcor Puritan Bennett France Dvpt. (2000) Summary page 1.

## Indications for use
The Puritan Bennett GoodKnight 420 Evolution is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

Source page: https://510kreport.com/device/K031470
Methodology: https://510kreport.com/methodology