Cleared Abbreviated

AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (K081345) - FDA 510(k) Clearance

Class I Hematology device.

K081345 · Thermogenesis Corp. · Hematology device
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Jul 2008
Decision
57d
Days
Class 1
Risk

K081345 is an FDA 510(k) clearance for the AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY). Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on July 10, 2008 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Thermogenesis Corp. devices

Submission Details

510(k) Number K081345 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 14, 2008
Decision Date July 10, 2008
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 113d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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.

Regulatory Peers - JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 37
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K081345.
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UNIVERSAL 2 S CENTRIFUGE
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EBA 3 S CENTRIFUGE
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