Cleared Traditional

K823710 - DISPOSABLE AIRWAY ADEJUNCT

K823710 is an FDA 510(k) clearance for DISPOSABLE AIRWAY ADEJUNCT, manufactured by Groves Medical Supply, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K823710 · Groves Medical Supply, Inc. · Anesthesiology device
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Jan 1983
Decision
43d
Days
Class 2
Risk

K823710 is an FDA 510(k) clearance for the DISPOSABLE AIRWAY ADEJUNCT. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Groves Medical Supply, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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.

FDA 510(k) Submission Details - K823710

510(k) Number K823710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1982
Decision Date January 21, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 165
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K823710.
MARK III RESUSCITATOR
K840349 · Ambu, Inc. · Feb 1984
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983
SC-603 TWIN VALVE
K831486 · Instrumentation Industries, Inc. · Aug 1983
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · Instrumentation Industries, Inc. · Dec 1982
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · Siemens Elema AB · Oct 1982
RESUSCITATION CIRCUIT
K812273 · Vital Signs, Inc. · Aug 1981
K823710 · DISPOSABLE AIRWAY ADEJUNCT
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