510(k) · Cleared
Recalled · 2011Tempus IC Professional Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remote Diagnostic Technologies, Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 11, 2010 as substantially equivalent to K921497 (Protocol Systems, Inc., 1993) and 4 other predicates after a 6-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2010
- Review
- 6 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 1 generation to K910772 (1991). 5 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- This deviceK101264 Tempus IC Professional Patient MonitorRemote Diagnostic Technologies, Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 3 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK130773 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · cites it directly8descendants
- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 2 generations on7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 3 generations on6descendants
- K130773Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2013 · cites it directly6descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| 0 (this device) | K101264 | Tempus IC Professional Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2010 | — |
| +1 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +2 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +3 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +1 | K130773 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2013 | 1 |
| +4 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K082715 | FDA’s K082715 is Depuy Global AP Cta Humeral Head 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…e Devices The Tempus IC Professional Patient Monitor is predicated on our existing model, the Tempus IC Patient Monitor, which was the subject of a previous submissions (K082715), and is being cited as the predicate for this new finished device (in addition to other predicates most notably the Propaq 102 w… | 2008 |
| * | K921497 | Propaq Monitors, ModificationSummary page 2…missions (K082715), and is being cited as the predicate for this new finished device (in addition to other predicates most notably the Propaq 102 which was cleared under K921497, K914838, K910882 and K910772). The Tempus IC Professional Patient Monitor is the same hardware as the predicate (excepting a rev… | 1993 |
| * | K914838 | Propaq 102,104,106,102EL,104EL,&106ELSummary page 2…(K082715), and is being cited as the predicate for this new finished device (in addition to other predicates most notably the Propaq 102 which was cleared under K921497, K914838, K910882 and K910772). The Tempus IC Professional Patient Monitor is the same hardware as the predicate (excepting a revised memb… | 1992 |
| * | K910882 | Propaq 102EL, 104EL and 106ELSummary page 2…, and is being cited as the predicate for this new finished device (in addition to other predicates most notably the Propaq 102 which was cleared under K921497, K914838, K910882 and K910772). The Tempus IC Professional Patient Monitor is the same hardware as the predicate (excepting a revised membrane keyp… | 1991 |
| * | K910772 | Propaq 102, 104 and 106Summary page 2…ng cited as the predicate for this new finished device (in addition to other predicates most notably the Propaq 102 which was cleared under K921497, K914838, K910882 and K910772). The Tempus IC Professional Patient Monitor is the same hardware as the predicate (excepting a revised membrane keypad and offer… | 1991 |
| * | K011059 | Infared Ear Thermometer, Model TH8 SeriesSummary page 2…ame personnel (trained healthcare professionals) for the same patients (adults and children). Lastly, the Radiant Innovations TH809 thermometer is cited as a predicate (K01 1059) for the modified version (that provides Bluetooth communications of the measured readings) that will be provided with the Tempus… | 2001 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2011 | Not classified | Z-2183-2011 | Component change control | It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
- Of its descendants, K113105 (Remote Diagnostic Technologies, Ltd., 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (119 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101264: Tempus IC Professional Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101264
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026