510(k) · Cleared
ClearedTempusic 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 Dec 15, 2011 as substantially equivalent to K082718 (Remote Diagnostic Technologies, Ltd., 2008) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1987. 8 later devices descend from it.
- Decided
- Dec 15, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K864318 (1987). 24 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 4 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 3 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 2 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 1 generation backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- This deviceK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 2 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 5 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · cites it directly7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 2 generations on6descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 3 generations on5descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 4 generations on4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −4 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −3 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −2 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −1 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| 0 (this device) | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +1 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +2 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +3 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
| +4 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +5 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082718 | Tempusic Patient MonitorSummary page 3…on itself (as cleared to market without the ability to receive data from the thermometer or the MyGlucoHealth device). The clearance for the Tempus IC was granted under K082718. The use of the tympanic thermometer is predicated on the clearance of the same thermometer with the Tempus IC Professional (gra… | 2008 |
| * | K101264 | Tempus IC Professional Patient MonitorSummary page 1…e exception that the device is now capable of receiving (wirelessly over a BluetoothM link) both tympanic temperature readings from a tvmpanic thermometer (cleared under K101264) and blood glucose data from the Entra Health Systems MvGlucoHealth gilucometer (cleared under K081 703). Voice and data connect… | 2010 |
| * | K081703 | Myglucohealth Glucose Monitoring SystemsSummary page 1…ic temperature readings from a tvmpanic thermometer (cleared under K101264) and blood glucose data from the Entra Health Systems MvGlucoHealth gilucometer (cleared under K081 703). Voice and data connections are made automatically via existing satellite or terrestrial communications systems. The TempusICT… | 2009 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152124 | Tempus IC2 | 2015 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K152124 (Remote Diagnostics Technologies, Ltd., 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K082718.
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. 2011, 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?
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…
Read the full statement (195 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113105: Tempusic 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/K113105
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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