Cleared Traditional

K885091 - HEMAVIEW DARKFIELD MICROSCOPE SYSTEM (FDA 510(k) Clearance)

Class I Pathology device.

K885091 · Technalysis, Inc. · Pathology device
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Jun 1989
Decision
183d
Days
Class 1
Risk

K885091 is an FDA 510(k) clearance for the HEMAVIEW DARKFIELD MICROSCOPE SYSTEM. Classified as Microscope, Phase Contrast (product code IBM), Class I - General Controls.

Submitted by Technalysis, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on June 13, 1989 after a review of 183 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3600 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Technalysis, Inc. devices

Submission Details

510(k) Number K885091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date June 13, 1989
Days to Decision 183 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 77d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IBM Microscope, Phase Contrast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3600
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.