Cleared Traditional

K851660 - DONWAY LIFTING FRAME (FDA 510(k) Clearance)

Class I General Hospital device.

K851660 · Australian Biomedical Corporation , Ltd. · General Hospital
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Aug 1985
Decision
106d
Days
Class 1
Risk

K851660 is an FDA 510(k) clearance for the DONWAY LIFTING FRAME. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 7, 1985 after a review of 106 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 Australian Biomedical Corporation , Ltd. devices

Submission Details

510(k) Number K851660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date August 07, 1985
Days to Decision 106 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
22d faster than avg
Panel avg: 128d · This submission: 106d
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.