# K980365: Goodknight 418 Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jul 22, 1998 after 174 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: 2 generations back to K903764 (1990). 5 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960518: The Puritan-Bennett 318 Plus Nasal Cpap System, Puritan Bennett Corp. (1996) Summary page 1.

## Most influential descendants
- K991150: Nellcor Puritan Bennett, Goodknight 418G (1999), 28 descendants of its own
- K993584: Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 (2000), 22 descendants of its own
- K030985: Breas PV 10I Cpap System, Model PV 10I (2003), 20 descendants of its own
- K063476: Breas Isleep 20I (2007), 12 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own

## Indications for use
The GoodKnight 418 CPAP System is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare environment.

Source page: https://510kreport.com/device/K980365
Methodology: https://510kreport.com/methodology