Cleared Traditional

K963466 - PEDIATRIC LIMB HOLDER

K963466 is the FDA 510(k) clearance for PEDIATRIC LIMB HOLDER by Deroyal Industries, Inc.. It is a Class 1 General Hospital device (product code FMQ) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K963466 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
163d
Days
Class 1
Risk

K963466 is an FDA 510(k) clearance for the PEDIATRIC LIMB HOLDER. 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 February 13, 1997 after a review of 163 days - an extended review 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: 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 K963466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date February 13, 1997
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 K963466.
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
RESTRICTIVE LIMB HOLDER
K963468 · Deroyal Industries, Inc. · Jan 1997
TUXEDO VEST RESTRAINT
K963474 · 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