# K033410: Tempus 2000 Patient Monitor, Model 00-0002

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Mar 5, 2004 after 130 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: 3 generations back to K864318 (1987). 11 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K010436: Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011, Remote Diagnostic Technologies, Ltd. (2001) Summary page 5.
- K973318: Mobimed System, (Pegasus and Polaris), Ortivus Us, Inc. (1998) Summary page 5.
- K964408: Poseidon Cardiac Monitoring System (PCMS), Instromedix, Inc. (1997) Summary page 5.

## Most influential descendants
- K082718: Tempusic Patient Monitor (2008), 14 descendants of its own
- 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

## Indications for use
The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present. The device is intended to be applied to the patient by a trained operator who is not a medical expert. The device is not intended to allow the operator to make any clinical decision for treatment or diagnosis. The device permits the operator to take measurements from a patient, store this information for later transmission or transmit medical information to a Response Centre at the time of recording, where trained staff can make clinical assessments based on the information transmitted and advise the operator on the nature of the medical incident. A trained physician may use the Tempus 2000 Patient Monitor as a standalone diagnostic device. The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Source page: https://510kreport.com/device/K033410
Methodology: https://510kreport.com/methodology