# K152946: Tempedy

- Pathway: 510(k) (Traditional)
- Applicant: Seiratherm GmbH
- Decided: Sep 15, 2016 after 345 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- 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
Longest line of descent: 6 generations back to K811742 (1981). 29 ancestors in all.
No later device cites it as a predicate yet.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080899: Arctic Blast Intravenous Fluid Chiller, Medivance, Inc. (2008) Summary page 5.
- K082217: Ranger Rapid Flow Blood/Fluid Warming System, Arizant Healthcare, Inc. (2008) Summary page 5.
- K080908: Innercool Therapies, Inc., Rapidblue System, Innercool Therapies, Inc.- A Delaware Corporation (2008) Summary page 5.

## Indications for use
The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.

Source page: https://510kreport.com/device/K152946
Methodology: https://510kreport.com/methodology