Cleared Traditional

K953763 - GLADIATOR ANTISHOCK PANTS

K953763 is an FDA 510(k) clearance for GLADIATOR ANTISHOCK PANTS, manufactured by Jobst Institute, Inc.. The device is a Class 2 Anesthesiology device with product code LHX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K953763 · Jobst Institute, Inc. · Anesthesiology device
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Nov 1995
Decision
109d
Days
Class 2
Risk

K953763 is an FDA 510(k) clearance for the GLADIATOR ANTISHOCK PANTS. Classified as Trousers, Anti-shock (product code LHX), Class II - Special Controls.

Submitted by Jobst Institute, Inc. (Charlotte, US). The FDA issued a Cleared decision on November 28, 1995 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.5800 - 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 Jobst Institute, Inc. devices

FDA 510(k) Submission Details - K953763

510(k) Number K953763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1995
Decision Date November 28, 1995
Days to Decision 109 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 faster than avg
Panel avg: 140d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHX Device Classification - Class 2, Special Controls

Product Code LHX Trousers, Anti-shock
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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.