510(k) · Cleared
ClearedTempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011
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 May 14, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- May 14, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK010436 Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring…Remote Diagnostic Technologies, Ltd. · 2001
- Descendant · cites it directly · 15 of its ownK033410 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
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033410Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004 · cites it directly15descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model… | Remote Diagnostic Technologies, Ltd. | 2001 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033410 (Remote Diagnostic Technologies, Ltd., 2004) has gone furthest, with 15 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.
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 | — |
https://510kreport.com/device/K010436 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010436: Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010436
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026