Cleared Traditional

K932852 - NON INVASIVE VASCULAR PROGRAM (FDA 510(k) Clearance)

Class I General Hospital device.

K932852 · D. E. Hokanson, Inc. · General Hospital
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Feb 1994
Decision
239d
Days
Class 1
Risk

K932852 is an FDA 510(k) clearance for the NON INVASIVE VASCULAR PROGRAM. Classified as Hexane Extraction, Fluorescence, Vitamin E (product code JOB), Class I - General Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 239 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1815 - 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 D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K932852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1993
Decision Date February 04, 1994
Days to Decision 239 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 128d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JOB Hexane Extraction, Fluorescence, Vitamin E
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1815
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.