# K073363: Thermostat 900 Administration Set, Model Ash 100, 200 and 300

- Pathway: 510(k) (Traditional)
- Applicant: Paladin Biomedical Corporation
- Decided: Mar 20, 2008 after 111 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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
- K970045: Solaro 33, Metalor Dental USA Corp. (1997). The summary prints BK970045, a CBER number, which our reading took as K970045, FDA’s number for Solaro 33 (Metalor Dental USA Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ThermoStat 900 Blood & IV Fluid Adm. Set”. Kept off the family tree. Summary page 4.

## Indications for use
Paladin Biomedical Corporation ThermoStat 900 Administration Set is intended to be used with the MMS Thermostat 900 Blood and Fluid Warmer. The disposable cartridge and administration set is intended to deliver high volume, rapid administration of blood and physiological fluids when connected to a large bore catheter. The set is intended to help prevent hypothermia in patients receiving large volumes of fluids.

Source page: https://510kreport.com/device/K073363
Methodology: https://510kreport.com/methodology