Cleared Traditional

K863686 - BACK REST, LITTER, NON-ADJUSTABLE

K863686 is an FDA 510(k) clearance for BACK REST, manufactured by Brenner Metal Prod Corp.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K863686 · Brenner Metal Prod Corp. · General Hospital
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Jan 1987
Decision
123d
Days
Class 1
Risk

K863686 is an FDA 510(k) clearance for the BACK REST, LITTER, NON-ADJUSTABLE. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Brenner Metal Prod Corp. (Wallington, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 123 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - 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 Brenner Metal Prod Corp. devices

FDA 510(k) Submission Details - K863686

510(k) Number K863686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date January 20, 1987
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 129d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

FPP Device Classification - Class 1, General Controls

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
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.