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. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 10, 2008 as substantially equivalent to K033410 (Remote Diagnostic Technologies, Ltd., 2004) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1987. 14 later devices descend from it.
- Decided
- Oct 10, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K864318 (1987). 12 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 3 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 2 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 1 generation backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- This deviceK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- 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 · 4 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
- Descendant · 5 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
- K170798Dictum HealthDictum Health, Inc. · 2017 · 4 generations on5descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −3 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −2 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −1 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| 0 (this device) | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| +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 | — |
| +4 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
| +5 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033410 | Tempus 2000 Patient Monitor, Model 00-0002Summary page 3…ht). Predicate Devices The TempusIC has been shown to be substantially equivalent to the Tempus 2000 Patient Monitor, which was the subject of two previous submissions (K033410 & K84--1e-64). K 0104346 Operation of the new device is essentially the same in terms of medical and communications function, but… | 2004 |
| Kept off the family tree | K041064 | FDA’s K041064 is Bioknotless RC Anchor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011 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”. | 2001 |
What descends from it? (14)
See all 142 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)
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 21 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 12 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 DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
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 (162 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 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/K082718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082718: 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/K082718
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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