Cleared Traditional

K810348 - CM 3

K810348 is an FDA 510(k) clearance for CM 3, manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810348 · Instrumentation Industries, Inc. · Anesthesiology device
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Feb 1981
Decision
13d
Days
Class 2
Risk

K810348 is an FDA 510(k) clearance for the CM 3. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Walker, US). The FDA issued a Cleared decision on February 23, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Instrumentation Industries, Inc. devices

FDA 510(k) Submission Details - K810348

510(k) Number K810348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date February 23, 1981
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 62
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K810348.
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
RESUSCITATION VALVE
K832868 · Boehringer Laboratories · Sep 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246 · Airlife, Inc. · Jul 1983
RETARD VALVE 3-STACK #M-515
K791907 · Mem Medical, Inc. · Oct 1979
RETARD VALVE 3-STACK #M-514
K791908 · Mem Medical, Inc. · Oct 1979
ONE-WAY VALVE-MALE, M-504
K791849 · Mem Medical, Inc. · Oct 1979