Cleared Traditional

K963409 - POSEY HUGGER

K963409 is the FDA 510(k) clearance for POSEY HUGGER by J. T. Posey Co.. It is a Class 1 General Hospital device (product code FMQ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K963409 · J. T. Posey Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
76d
Days
Class 1
Risk

K963409 is an FDA 510(k) clearance for the POSEY HUGGER. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by J. T. Posey Co. (Arcadia, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 76 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 J. T. Posey Co. devices

Submission Details

510(k) Number K963409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 14, 1996
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 32
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963409.
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
MITTENS
K963469 · Deroyal Industries, Inc. · Nov 1996
CRISS-CROSS VEST RESTRAINT
K963470 · Deroyal Industries, Inc. · Nov 1996
SUPER SECURITY RESTRAINT
K963471 · Deroyal Industries, Inc. · Nov 1996