# K113105: Tempusic Patient Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Dec 15, 2011 after 56 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864318 (1987). 24 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082718: Tempusic Patient Monitor, Remote Diagnostic Technologies, Ltd. (2008) Summary page 3.
- K101264: Tempus IC Professional Patient Monitor, Remote Diagnostic Technologies, Ltd. (2010) Summary page 1.
- K081703: Myglucohealth Glucose Monitoring Systems, Entra Health Systems, Ltd. (2009) Summary page 1.

## Most influential descendants
- K152124: Tempus IC2 (2015), 7 descendants of its own
- K152645: Dictum Health (2016), 6 descendants of its own
- K170798: Dictum Health (2017), 5 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own

## Indications for use
Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident. Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required. Tempus IC measures non-invasive blood pressure, SpO 2, pulse rate, respiration rate and ETCO 2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module). Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Source page: https://510kreport.com/device/K113105
Methodology: https://510kreport.com/methodology