# K993584: Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2

- Pathway: 510(k) (Abbreviated)
- Applicant: Nellcor Puritan Bennett France Dvpt.
- Decided: Mar 7, 2000 after 137 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: 4 generations back to K903764 (1990). 7 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991150: Nellcor Puritan Bennett, Goodknight 418G, Nellcor Puritan Bennett France Dvpt. (1999) Summary page 1.

## Most influential descendants
- 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
- K042945: Aura Cpap System (2005), 6 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own

## Indications for use
The Mallinckrodt GoodKnight 418 Series 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/K993584
Methodology: https://510kreport.com/methodology