# K970365: Passy-Muir O2 Adapter; PMA2000

- Pathway: 510(k) (Traditional)
- Applicant: Passy-Muir, Inc.
- Decided: Feb 12, 1997 after 12 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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) Trach Ring Adapter (Marquest Medical), Product # 178548: named in the summary without a submission number
- (no number) Aerosol Tee Connector (Hudson RCI), Product # 1648: named in the summary without a submission number
- (no number) Tracheostomy Mask (Hudson RCI), Product # 1075: named in the summary without a submission number

## Indications for use
The P-M O₂ Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.

Source page: https://510kreport.com/device/K970365
Methodology: https://510kreport.com/methodology