Cleared Traditional

K963450 - SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST

K963450 is an FDA 510(k) clearance for SAFETY VEST/SHOULDER STRAP VEST/ECONOMY..., manufactured by Skil-Care Corp.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K963450 · Skil-Care Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
34d
Days
Class 1
Risk

K963450 is an FDA 510(k) clearance for the SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 34 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 Skil-Care Corp. devices

FDA 510(k) Submission Details - K963450

510(k) Number K963450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 07, 1996
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 122
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963450.
DOUBLE SUPPORT PONCHO/SLIDER PONCHO
K963447 · Skil-Care Corp. · Oct 1996
ECONO BELT
K963448 · Skil-Care Corp. · Oct 1996
PELVIC HOLDER
K963449 · Skil-Care Corp. · Oct 1996
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT
K963454 · Skil-Care Corp. · Oct 1996
PATIENT PROTECTIVE LIMB
K962626 · Kenad SG Medical, Inc. · Oct 1996
HEELBO BLAZER SLEEVED JACKET
K963243 · Heelbo, Inc. · Oct 1996