Cleared Special

K024128 - ALLON 2001 VERSION 5

K024128 is an FDA 510(k) clearance for ALLON 2001 VERSION 5, manufactured by Mtre Advanced Technology , Ltd.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 56-day FDA review.

K024128 · Mtre Advanced Technology , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
56d
Days
Class 2
Risk

K024128 is an FDA 510(k) clearance for the ALLON 2001 VERSION 5. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Mtre Advanced Technology , Ltd. (Centerville, US). The FDA issued a Cleared decision on February 10, 2003 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mtre Advanced Technology , Ltd. devices

FDA 510(k) Submission Details - K024128

510(k) Number K024128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date February 10, 2003
Days to Decision 56 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 69
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