# K964019: Morphee Plus Alpha

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Jun 18, 1997 after 254 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Companion 318 Nasal CPAP System - Nellcor Purtitan Bennett: named in the summary without a submission number
- (no number) DPAP Interactive Airway Management System - SleepNet Corporation: named in the summary without a submission number

## Indications for use
The Morphee Plus Alpha is intended to manage obstructive sleep apnea by delivering air pressure through a tube and mask. It is intended for use in either the hospital or home environment.

Source page: https://510kreport.com/device/K964019
Methodology: https://510kreport.com/methodology