Cleared Traditional

K821128 - DISPOSABLE THERMOPLASTIC RUBBER MOUTH

K821128 is an FDA 510(k) clearance for DISPOSABLE THERMOPLASTIC RUBBER MOUTH, manufactured by Airlife, Inc.. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821128 · Airlife, Inc. · Anesthesiology device
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May 1982
Decision
23d
Days
Class 1
Risk

K821128 is an FDA 510(k) clearance for the DISPOSABLE THERMOPLASTIC RUBBER MOUTH. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 after a review of 23 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 Airlife, Inc. devices

FDA 510(k) Submission Details - K821128

510(k) Number K821128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 13, 1982
Days to Decision 23 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
117d faster than avg
Panel avg: 140d · This submission: 23d
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 15
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K821128.
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
MOUTHPIECE, BREATHING
K810793 · Dhd Medical Products Div. Diemolding Corp. · May 1981
DISPOSABLE MOUTHPIECE
K791537 · Hospitak, Inc. · Sep 1979
CORRUGATED TUBE WITH MOUTHPIECE
K790931 · Mem Medical, Inc. · May 1979