Cleared Traditional

K955657 - NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K955657 · North State Plastics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
91d
Days
Class 1
Risk

K955657 is an FDA 510(k) clearance for the NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by North State Plastics, Inc. (Denver, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5620 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all North State Plastics, Inc. devices

Submission Details

510(k) Number K955657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date March 12, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 139d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYP Mouthpiece, Breathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.