Cleared Special

ALLON 2001 (K001546) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001546 · Mtre Advanced Technology , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
21d
Days
Class 2
Risk

K001546 is an FDA 510(k) clearance for the ALLON 2001. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Mtre Advanced Technology , Ltd. (Mccordsville, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 21 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

Submission Details

510(k) Number K001546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date June 08, 2000
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 157
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K001546.
Hot Pink Pad Warming System
K260903 · Xodus Medical, Inc. · Apr 2026
Warming System
K252861 · Hangzhou Tappa Medical Technology Co., Ltd. · Apr 2026
Arctic Sun Temperature Management System (Model 5000)
K251974 · Medivance, Inc. · Oct 2025
Celsi Warmer
K242964 · Hadleigh Health Technologies · Jun 2025
Arctic Sun Stat Temperature Management System
K243942 · Medivance, Inc. · Apr 2025
HotDog Warming Mattress + Return Electrode
K232627 · Augustine Temperature Management, LLC · Apr 2024