Cleared Traditional

K904267 - ZOEX ANTISHOCK TROUSERS

K904267 is an FDA 510(k) clearance for ZOEX ANTISHOCK TROUSERS, manufactured by Zoex Corp.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K904267 · Zoex Corp. · Cardiovascular device
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Mar 1991
Decision
181d
Days
Class 2
Risk

K904267 is an FDA 510(k) clearance for the ZOEX ANTISHOCK TROUSERS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Zoex Corp. (Palo Alto, US). The FDA issued a Cleared decision on March 18, 1991 after a review of 181 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Zoex Corp. devices

FDA 510(k) Submission Details - K904267

510(k) Number K904267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1990
Decision Date March 18, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 290
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K904267.
COWBOY
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K890938 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1989
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
K881632 · Huntleigh Technology, Inc. · Sep 1988