# K140078: Tecotherm Neo (T Neo)

- Pathway: 510(k) (Abbreviated)
- Applicant: Inspiration Healthcare, Ltd.
- Decided: Nov 14, 2014 after 305 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003349 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083662: Criticool, Mtre Advanced Technology, Ltd. (2009) Summary page 4.
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000, Medivance, Inc. (2007) Summary page 4.
- K024128: Allon 2001 Version 5, Mtre Advanced Technology, Ltd. (2003) Summary page 4.

## Recalls of this device
- Aug 14, 2018 · Class II · Z-0362-2020: The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer b

## Indications for use
The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient’s temperature through conductive heat transfer.

Source page: https://510kreport.com/device/K140078
Methodology: https://510kreport.com/methodology