# K992386: ALLON 2000

- Pathway: 510(k) (Traditional)
- Applicant: Mtre Advanced Technology, Ltd.
- Decided: Mar 7, 2000 after 235 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K114385: Blanketrol II System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The Allon 2000 System 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. The Allon 2000 System is indicated primarily 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/K992386
Methodology: https://510kreport.com/methodology