Cleared Traditional

K102704 - EASY CUFF

K102704 is an FDA 510(k) clearance for EASY CUFF, manufactured by Joan Spiegel, MD. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K102704 · Joan Spiegel, MD · Anesthesiology device
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Mar 2011
Decision
171d
Days
Class 2
Risk

K102704 is an FDA 510(k) clearance for the EASY CUFF. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Joan Spiegel, MD (Bonita Springs, US). The FDA issued a Cleared decision on March 10, 2011 after a review of 171 days - an extended review cycle.

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 Joan Spiegel, MD devices

FDA 510(k) Submission Details - K102704

510(k) Number K102704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date March 10, 2011
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 140d · This submission: 171d
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 20
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K102704.
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012
CUFF SENTRY
K102674 · Ventlab Corp. · Jul 2011
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · Instrumentation Industries, Inc. · Nov 1988