# K082718: Tempusic Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Oct 10, 2008 after 23 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864318 (1987). 12 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033410: Tempus 2000 Patient Monitor, Model 00-0002, Remote Diagnostic Technologies, Ltd. (2004) Summary page 3.
- K010436: Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011, Remote Diagnostic Technologies, Ltd. (2001). Our reading of the summary gave K010434, FDA’s number for Optetrak B-Series Total Knee System (Exactech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tempus 2000 Patient Monitor”.

## Cited in the summary but kept off the family tree
- K041064: Bioknotless RC Anchor, Depuy Mitek (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113105: Tempusic Patient Monitor (2011), 8 descendants of its own
- 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

## 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 is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Source page: https://510kreport.com/device/K082718
Methodology: https://510kreport.com/methodology