# K003349: Allon 2001 Modified

- Pathway: 510(k) (Special)
- Applicant: Mtre Advanced Technology, Ltd.
- Decided: Nov 13, 2000 after 18 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K024128: Allon 2001 Version 5 (2003), 17 descendants of its own
- K083662: Criticool (2009), 16 descendants of its own
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 (2011), 9 descendants of its own

Source page: https://510kreport.com/device/K003349
Methodology: https://510kreport.com/methodology