# K955657: North State Plastics Respiratory Mouthpiece

- Pathway: 510(k) (Traditional)
- Applicant: North State Plastics, Inc.
- Decided: Mar 12, 1996 after 91 days
- Product code: BYP (Mouthpiece, Breathing)
- Device class: 1
- Regulation: 21 CFR 868.5620
- 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) Hudson: named in the summary without a submission number
- (no number) Baxter: named in the summary without a submission number
- (no number) Marquest: named in the summary without a submission number
- (no number) Pari: named in the summary without a submission number
- (no number) Precision: named in the summary without a submission number
- (no number) Salter: named in the summary without a submission number

## Indications for use
The North State Plastics device is intended for use in providing a direct source of continuous aerosol medication.

Source page: https://510kreport.com/device/K955657
Methodology: https://510kreport.com/methodology