Cleared Traditional

K932852 - NON INVASIVE VASCULAR PROGRAM

K932852 is an FDA 510(k) clearance for NON INVASIVE VASCULAR PROGRAM, manufactured by D. E. Hokanson, Inc.. The device is a Class 1 General Hospital device with product code JOB cleared through the Traditional 510(k) pathway after a 239-day FDA review.

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

FDA 510(k) Submission Details - K932852

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

JOB Device Classification - Class 1, General Controls

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.