Cleared Traditional

RESTRAINING STRETCHER (K924275) - FDA 510(k) Clearance

Class I General Hospital device.

K924275 · Dms · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
336d
Days
Class 1
Risk

K924275 is an FDA 510(k) clearance for the RESTRAINING STRETCHER. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Dms (Soiux Falls, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dms devices

Submission Details

510(k) Number K924275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date July 27, 1993
Days to Decision 336 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
207d slower than avg
Panel avg: 129d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.