Cleared Traditional

K953519 - MICROSPIN 24

K953519 is an FDA 510(k) clearance for MICROSPIN 24, manufactured by Vulcon Technologies. The device is a Class 2 Hematology device with product code GKF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K953519 · Vulcon Technologies · Hematology device
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Nov 1995
Decision
99d
Days
Class 2
Risk

K953519 is an FDA 510(k) clearance for the MICROSPIN 24. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by Vulcon Technologies (Grandview, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - 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 Vulcon Technologies devices

FDA 510(k) Submission Details - K953519

510(k) Number K953519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date November 03, 1995
Days to Decision 99 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
14d faster than avg
Panel avg: 113d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKF Device Classification - Class 2, Special Controls

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
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 - GKF Instrument, Hematocrit, Automated

All 11
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K953519.
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
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STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · Nova Biomedical Corp. · May 1998
STAT PROFILE M ANALYZER
K981427 · Nova Biomedical Corp. · May 1998
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825 · Fisher Scientific Co., LLC · Mar 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · Fisher Scientific Co., LLC · Jan 1992
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336 · Cobe Laboratories, Inc. · Dec 1990