Cleared Traditional

K904237 - RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (FDA 510(k) Clearance)

Class I General Hospital device.

K904237 · Innovative Medical Technologies, Inc. · General Hospital
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May 1991
Decision
234d
Days
Class 1
Risk

K904237 is an FDA 510(k) clearance for the RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Innovative Medical Technologies, Inc. (V2c5a9, CA). The FDA issued a Cleared decision on May 9, 1991 after a review of 234 days - an extended review cycle.

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 Innovative Medical Technologies, Inc. devices

Submission Details

510(k) Number K904237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date May 09, 1991
Days to Decision 234 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
106d slower than avg
Panel avg: 128d · This submission: 234d
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.