Cleared Traditional

K915825 - MARATHON 6K GENERAL-PURPOSE CENTRIFUGE

K915825 is the FDA 510(k) clearance for MARATHON 6K GENERAL-PURPOSE 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 72-day FDA review.

K915825 · Fisher Scientific Co., LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
72d
Days
Class 2
Risk

K915825 is an FDA 510(k) clearance for the MARATHON 6K GENERAL-PURPOSE 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 March 11, 1992 after a review of 72 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 K915825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date March 11, 1992
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
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 K915825.
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425 · Nova Biomedical Corp. · May 1998
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 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · Fisher Scientific Co., LLC · Jan 1992
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336 · Cobe Laboratories, Inc. · Dec 1990
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1987