# K101264: Tempus IC Professional Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: May 11, 2010 after 6 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 1 generation back to K910772 (1991). 5 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921497: Propaq Monitors, Modification, Protocol Systems, Inc. (1993) Summary page 2.
- K914838: Propaq 102,104,106,102EL,104EL,&106EL, Protocol Systems, Inc. (1992) Summary page 2.
- K910882: Propaq 102EL, 104EL and 106EL, Protocol Systems, Inc. (1991) Summary page 2.
- K910772: Propaq 102, 104 and 106, Protocol Systems, Inc. (1991) Summary page 2.
- K011059: Infared Ear Thermometer, Model TH8 Series, Radiant Innovation, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K082715: Depuy Global AP Cta Humeral Head, DePuy Orthopaedics, Inc. (2008). Our reading of the summary gave K082715, FDA’s number for Depuy Global AP Cta Humeral Head (DePuy Orthopaedics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Tempus IC Patient Monitor”. Kept off the family tree. Summary page 2.

## 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
- K130773: Tempus Pro Patient Monitor (2013), 6 descendants of its own
- K170798: Dictum Health (2017), 5 descendants of its own

## Recalls of this device
- Mar 25, 2011 · Not classified · Z-2183-2011: It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.

## Indications for use
The Tempus IC Professional is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 Lead EGG monitoring and 12 Lead EGG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SPO 2 ) and tympanic temperature. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patieht data to other medical professionals located elsewhere). The EGG Harness of the Tempus IC Professional is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Source page: https://510kreport.com/device/K101264
Methodology: https://510kreport.com/methodology