Cleared Traditional

K963477 - PEDIATRIC MITTENS

K963477 is the FDA 510(k) clearance for PEDIATRIC MITTENS by Deroyal Industries, Inc.. It is a Class 1 General Hospital device (product code FMQ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K963477 · Deroyal Industries, Inc. · General Hospital
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Nov 1996
Decision
70d
Days
Class 1
Risk

K963477 is an FDA 510(k) clearance for the PEDIATRIC MITTENS. 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 November 12, 1996 after a review of 70 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K963477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date November 12, 1996
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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.

Regulatory Peers - FMQ Restraint, Protective

All 33
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963477.
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
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431 · Zimmer, Inc. · Nov 1996
HEELBO PELVIC RESTRAINT
K963199 · Hollister, Inc. · Nov 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · Depuy, Inc. · Oct 1996