# K122095: Icp Triagemanager

- Pathway: 510(k) (Traditional)
- Applicant: Emergo Europe Consulting BV
- Decided: Jul 26, 2012 after 14 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K864318 (1987). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103276: Intel Health Guide, Intel Corporation Digital Health Group (2011) Summary page 2.

## Indications for use
The Tunstall icp triagemanager software application allows the caregiver to review patient information and to motivate and provide educational information to the patient. The Tunstall icp triagemanager is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. Clinical judgment and experience by a caregiver are required to check and interpret the patient information delivered. The Tunstall icp triagemanager is not intended for real-time monitoring, is not an alarm system and may not be used to receive real-time or time-critical data, is not intended for patients requiring direct medical supervision or emergency intervention, and is not intended for direct diagnosis or monitoring.

Source page: https://510kreport.com/device/K122095
Methodology: https://510kreport.com/methodology