# K024128: Allon 2001 Version 5

- Pathway: 510(k) (Special)
- Applicant: Mtre Advanced Technology, Ltd.
- Decided: Feb 10, 2003 after 56 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003349 (2000). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003349: Allon 2001 Modified, Mtre Advanced Technology, Ltd. (2000) Summary page 2.
- (no number) Cincinnati Subzero - Blanketrol: named in the summary without a submission number

## Most influential descendants
- K083662: Criticool (2009), 16 descendants of its own
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 (2011), 9 descendants of its own
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (2014), 4 descendants of its own
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems (2010), 4 descendants of its own
- K152266: Altrix Precision Temperature Management System (2016), 3 descendants of its own

## Recalls of this device
- May 13, 2025 · Class II · Z-1966-2025: An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Contro

## Indications for use
The Allon 2001 version 5 is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K024128
Methodology: https://510kreport.com/methodology