Cleared Traditional

K924275 - RESTRAINING STRETCHER

K924275 is an FDA 510(k) clearance for RESTRAINING STRETCHER, manufactured by Dms. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 336-day FDA review.

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

FDA 510(k) Submission Details - K924275

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.

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.