Cleared Traditional

K810793 - MOUTHPIECE, BREATHING

K810793 is an FDA 510(k) clearance for MOUTHPIECE, manufactured by Dhd Medical Products Div. Diemolding Corp.. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K810793 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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May 1981
Decision
43d
Days
Class 1
Risk

K810793 is an FDA 510(k) clearance for the MOUTHPIECE, BREATHING. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Dhd Medical Products Div. Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 43 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 Dhd Medical Products Div. Diemolding Corp. devices

FDA 510(k) Submission Details - K810793

510(k) Number K810793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1981
Decision Date May 05, 1981
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
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 K810793.
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
DISPOSABLE MOUTHPIECE
K791537 · Hospitak, Inc. · Sep 1979
CORRUGATED TUBE WITH MOUTHPIECE
K790931 · Mem Medical, Inc. · May 1979
AEROSOL MOUTHPIECE NO. M-091
K790932 · Mem Medical, Inc. · May 1979