Cleared Traditional

SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS (K963485) - FDA 510(k) Clearance

Class I General Hospital device.

K963485 · Humane Restraint, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
80d
Days
Class 1
Risk

K963485 is an FDA 510(k) clearance for the SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB H.... Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Humane Restraint, Inc. (Waunakee, US). The FDA issued a Cleared decision on November 22, 1996 after a review of 80 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 Humane Restraint, Inc. devices

Submission Details

510(k) Number K963485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date November 22, 1996
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 11
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963485.
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431 · Zimmer, Inc. · Nov 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · Depuy, Inc. · Oct 1996
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
K963378 · Medline Industries, Inc. · Oct 1996
MEDLINE BODY HOLDER
K963360 · Medline Industries, Inc. · Oct 1996
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
K963362 · Medline Industries, Inc. · Oct 1996