510(k) · Cleared
ClearedTempus 2000 Patient Monitor, Model 00-0002
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 Mar 5, 2004 as substantially equivalent to K010436 (Remote Diagnostic Technologies, Ltd., 2001) and 2 other predicates after a 130-day review. Its family tree reaches back 3 generations to 1987. 15 later devices descend from it.
- Decided
- Mar 5, 2004
- Review
- 130 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864318 (1987). 11 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 2 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 1 generation backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- This deviceK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- Descendant · cites it directly · 14 of its ownK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- Descendant · 2 generations on · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 4 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · 5 generations on · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K082718Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008 · cites it directly14descendants
- K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · 2 generations on8descendants
- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 3 generations on7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 4 generations on6descendants
- K170798Dictum HealthDictum Health, Inc. · 2017 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −2 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −1 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| 0 (this device) | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| +1 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| +2 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +3 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +4 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +5 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011Summary page 5…owing predicate systems: Manufacturer Device Name 510(k) reference RDT Ltd. Tempus 2000 Patient Monitor (unmodified) K010436 Ortivus AB MobiMed Patient Monitor K973318 Instromedix Inc. Poseidon Cardiac Monitoring System… | 2001 |
| * | K973318 | Mobimed System, (Pegasus and Polaris)Summary page 5…510(k) reference RDT Ltd. Tempus 2000 Patient Monitor (unmodified) K010436 Ortivus AB MobiMed Patient Monitor K973318 Instromedix Inc. Poseidon Cardiac Monitoring System K964408 The modified Tempus 2000 is substantially equivalent t… | 1998 |
| * | K964408 | Poseidon Cardiac Monitoring System (PCMS)Summary page 5…Monitor (unmodified) K010436 Ortivus AB MobiMed Patient Monitor K973318 Instromedix Inc. Poseidon Cardiac Monitoring System K964408 The modified Tempus 2000 is substantially equivalent to the original design as cleared to market by the FDA. The product provide… | 1997 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082718 | Tempusic Patient Monitor | 2008 | 14 |
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 17 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K082718 (Remote Diagnostic Technologies, Ltd., 2008) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K010436.
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.
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?
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…
Read the full statement (151 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033410: Tempus 2000 Patient Monitor, Model 00-0002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033410
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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