Cleared Traditional

K885091 - HEMAVIEW DARKFIELD MICROSCOPE SYSTEM

K885091 is an FDA 510(k) clearance for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM, manufactured by Technalysis, Inc.. The device is a Class 1 Pathology device with product code IBM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

FDA 510(k) Submission Details - K885091

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.

IBM Device Classification - Class 1, General Controls

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.