# K960518: The Puritan-Bennett 318 Plus Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: May 9, 1996 after 94 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: 1 generation back to K903764 (1990). 4 ancestors in all.
30 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)
- K952292: Puritan-Bennett Companion Nasal Cpap System, Puritan Bennett Corp. (1995) Summary page 1.
- K903764: Companion 318 Nasal Cpap System, Puritan Bennett Corp. (1990) Summary page 1.
- K942210: Puritan-Bennett 335 Respiratory Support System, Puritan Bennett Corp. (1996). Cleared while this submission was under review Summary page 1.
- K943509: 7300 Nasal Cpap System, Healthdyne Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K063476: Breas Isleep 20I (2007), 12 descendants of its own

## Indications for use
The intended use of the 318 Plus Nasal CPAP System is to provide Continuous Positive Airway Pressure (CPAP) between 3 and 18 cm H20 to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea in a homecare environment. This is the same intended use as for the C314 Nasal CPAP System.

Source page: https://510kreport.com/device/K960518
Methodology: https://510kreport.com/methodology