Cleared Traditional

K963491 - STUCKEY STRAP-3 FINGER RESTRAINTS

K963491 is an FDA 510(k) clearance for STUCKEY STRAP-3 FINGER RESTRAINTS, manufactured by Stuckey Ent., Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K963491 · Stuckey Ent., Inc. · General Hospital
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Nov 1996
Decision
72d
Days
Class 1
Risk

K963491 is an FDA 510(k) clearance for the STUCKEY STRAP-3 FINGER RESTRAINTS. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Stuckey Ent., Inc. (Corpus Christi, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stuckey Ent., Inc. devices

FDA 510(k) Submission Details - K963491

510(k) Number K963491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date November 14, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K963491.
PEDIATRIC VEST RESTRAINT
K963472 · Deroyal Industries, Inc. · Nov 1996
REUSABLE LIMB HOLDER
K963473 · Deroyal Industries, Inc. · Nov 1996
SLEEVED/SLEEVELESS VEST RESTRAINT
K963478 · Deroyal Industries, Inc. · Nov 1996
RESTRAINT NET
K963464 · Deroyal Industries, Inc. · Nov 1996
PEDIATRIC MITTENS
K963477 · Deroyal Industries, Inc. · Nov 1996
WHEEL CHAIR ACCESSORY
K963489 · Smith and Nephew Donjoy, Inc. · Nov 1996