# K903764: Companion 318 Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Sep 10, 1990 after 21 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960518: The Puritan-Bennett 318 Plus Nasal Cpap System (1996), 30 descendants of its own
- K980365: Goodknight 418 Cpap System (1998), 29 descendants of its own
- 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

Source page: https://510kreport.com/device/K903764
Methodology: https://510kreport.com/methodology