Cleared Traditional

K955657 - NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE

K955657 is an FDA 510(k) clearance for NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE, manufactured by North State Plastics, Inc.. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K955657

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

BYP Device Classification - Class 1, General Controls

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.

Regulatory Peers - BYP Mouthpiece, Breathing

All 16
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K955657.
TRUZONE PFM DISPOSABLE MOUTHPIECE
K944512 · Monaghan Medical Corp. · Nov 1994
AEROCHAMBER
K872037 · Monaghan Medical Corp. · Jul 1987
MP-4400 MOUTHPIECE-FLANGE SEAL
K862788 · Medipart Jerry Alexander · Aug 1986
MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410
K853572 · Medipart Jerry Alexander · Oct 1985
MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411
K853574 · Medipart Jerry Alexander · Oct 1985
MEDIPART MOUTHPIECE MP-1010
K853575 · Medipart Jerry Alexander · Oct 1985