Cleared Traditional

K080448 - CENTURION PROTECTIVE RESTRAINT, SCR SERIES (FDA 510(k) Clearance)

Class I General Hospital device.

K080448 · Tri-State Hospital Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
191d
Days
Class 1
Risk

K080448 is an FDA 510(k) clearance for the CENTURION PROTECTIVE RESTRAINT, SCR SERIES. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on August 28, 2008 after a review of 191 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 Tri-State Hospital Supply Corp. devices

Submission Details

510(k) Number K080448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date August 28, 2008
Days to Decision 191 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
63d slower than avg
Panel avg: 128d · This submission: 191d
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.