Cleared Traditional

K873614 - CBG CUFF MANOMETER

K873614 is an FDA 510(k) clearance for CBG CUFF MANOMETER, manufactured by Bio-Med Devices, Inc.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K873614 · Bio-Med Devices, Inc. · Anesthesiology device
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Jan 1988
Decision
136d
Days
Class 2
Risk

K873614 is an FDA 510(k) clearance for the CBG CUFF MANOMETER. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Madison, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Med Devices, Inc. devices

FDA 510(k) Submission Details - K873614

510(k) Number K873614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date January 22, 1988
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 140d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 - BSK Cuff, Tracheal Tube, Inflatable

All 19
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K873614.
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · Instrumentation Industries, Inc. · Nov 1988
CUFFCHECK
K881178 · Dhd Medical Products Div. Diemolding Corp. · Apr 1988
RESPIRONICS PR VALVE
K833327 · Respironics, Inc. · Nov 1983
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · Shiley, Inc. · Nov 1979