Cleared Traditional

K955766 - ADULT-PEDIATRIC TRANSPORT SYSTEM

K955766 is an FDA 510(k) clearance for ADULT-PEDIATRIC TRANSPORT SYSTEM, manufactured by International Biomedical, Inc.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K955766 · International Biomedical, Inc. · General Hospital
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Aug 1996
Decision
231d
Days
Class 2
Risk

K955766 is an FDA 510(k) clearance for the ADULT-PEDIATRIC TRANSPORT SYSTEM. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by International Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 231 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6910 - 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 International Biomedical, Inc. devices

FDA 510(k) Submission Details - K955766

510(k) Number K955766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1995
Decision Date August 07, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPO Device Classification - Class 2, Special Controls

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPO Stretcher, Wheeled

All 15
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