Cleared Traditional

K963474 - TUXEDO VEST RESTRAINT

K963474 is an FDA 510(k) clearance for TUXEDO VEST RESTRAINT, manufactured by Deroyal Industries, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K963474 · Deroyal Industries, Inc. · General Hospital
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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

FDA 510(k) Submission Details - K963474

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - FMQ Restraint, Protective

All 121
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963474.
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE
K962327 · Sekure Seat Corp. · Mar 1997
PEDIATRIC LIMB HOLDER
K963466 · Deroyal Industries, Inc. · Feb 1997
RESTRICTIVE LIMB HOLDER
K963468 · Deroyal Industries, Inc. · Jan 1997
DISPOSABLE LIMB HOLDER
K963476 · Deroyal Industries, Inc. · Jan 1997
ROLL BELTS
K963467 · Deroyal Industries, Inc. · Jan 1997
PELVIC HOLDER
K963465 · Deroyal Industries, Inc. · Dec 1996