Cleared Special

K003349 - ALLON 2001 MODIFIED

K003349 is an FDA 510(k) clearance for ALLON 2001 MODIFIED, 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 18-day FDA review.

K003349 · Mtre Advanced Technology , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
18d
Days
Class 2
Risk

K003349 is an FDA 510(k) clearance for the ALLON 2001 MODIFIED. 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 November 13, 2000 after a review of 18 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.

FDA 510(k) Submission Details - K003349

510(k) Number K003349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2000
Decision Date November 13, 2000
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
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 147
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K003349.
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
K011907 · Sims Level 1, Inc. · Dec 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · Medivance, Inc. · Mar 2001
ACROTHERM
K003368 · Aquarius Medical Corp. · Jan 2001
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
K002577 · Medivance, Inc. · Oct 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
K001149 · Augustine Medical, Inc. · Sep 2000
ALLON 2001
K001546 · Mtre Advanced Technology , Ltd. · Jun 2000
K003349 · ALLON 2001 MODIFIED
Download PDF FDA Summary Mtre Advanced Technol…