Cleared Traditional

K853402 - E-Z-GUARD MOUTHPIECE

K853402 is the FDA 510(k) clearance for E-Z-GUARD MOUTHPIECE by E-Z-Em, Inc.. It is a Class 1 Anesthesiology device (product code BYP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K853402 · E-Z-Em, Inc. · Anesthesiology device
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Oct 1985
Decision
72d
Days
Class 1
Risk

K853402 is an FDA 510(k) clearance for the E-Z-GUARD MOUTHPIECE. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K853402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date October 23, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 140d · This submission: 72d
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.

Regulatory Peers - BYP Mouthpiece, Breathing

All 10
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K853402.
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
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