Cleared Traditional

K920719 - IVOS ANALYZER

K920719 is an FDA 510(k) clearance for IVOS ANALYZER, manufactured by Hamilton Thorne Research. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K920719 · Hamilton Thorne Research · Hematology device
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Jun 1992
Decision
132d
Days
Class 2
Risk

K920719 is an FDA 510(k) clearance for the IVOS ANALYZER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Hamilton Thorne Research (Beverly, US). The FDA issued a Cleared decision on June 29, 1992 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hamilton Thorne Research devices

FDA 510(k) Submission Details - K920719

510(k) Number K920719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date June 29, 1992
Days to Decision 132 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 113d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 98
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