# K001546: ALLON 2001

- Pathway: 510(k) (Special)
- Applicant: Mtre Advanced Technology, Ltd.
- Decided: Jun 8, 2000 after 21 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D (2003), 11 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), 4 descendants of its own
- K141139: Solex Intravascular Heat Exchange Catheter (2014), 4 descendants of its own
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (2016), 3 descendants of its own

Source page: https://510kreport.com/device/K001546
Methodology: https://510kreport.com/methodology