Cleared Traditional

K963474 - TUXEDO VEST RESTRAINT (FDA 510(k) Clearance)

Class I General Hospital device.

K963474 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
141d
Days
Class 1
Risk

K963474 is an FDA 510(k) clearance for the TUXEDO VEST RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K963474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date January 22, 1997
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 128d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.