Cleared Traditional

K915441 - MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE

K915441 is the FDA 510(k) clearance for MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE by Fisher Scientific Co., LLC. It is a Class 2 Hematology device (product code GKF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K915441 · Fisher Scientific Co., LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
35d
Days
Class 2
Risk

K915441 is an FDA 510(k) clearance for the MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Indiana, US). The FDA issued a Cleared decision on January 8, 1992 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K915441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date January 08, 1992
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K915441.
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