Cleared Traditional

K833420 - KINETIX MOUTHPIECE

K833420 is an FDA 510(k) clearance for KINETIX MOUTHPIECE, manufactured by Kinetix. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K833420 · Kinetix · Anesthesiology device
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Jan 1984
Decision
99d
Days
Class 1
Risk

K833420 is an FDA 510(k) clearance for the KINETIX MOUTHPIECE. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Kinetix (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 99 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.

FDA 510(k) Submission Details - K833420

510(k) Number K833420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date January 10, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
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 18
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K833420.
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
E-Z-GUARD MOUTHPIECE
K853402 · E-Z-Em, Inc. · Oct 1985
MONAGHAN AEROCHAMBER
K822437 · Monaghan Medical Corp. · Nov 1982
DISPOSABLE THERMOPLASTIC RUBBER MOUTH
K821128 · Airlife, Inc. · May 1982
MOUTHPIECE, BREATHING
K810793 · Dhd Medical Products Div. Diemolding Corp. · May 1981
K833420 · KINETIX MOUTHPIECE
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