510(k) · Cleared
ClearedDatex-Ohmeda CS/3 Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 5, 2000 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jun 5, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK000882 Datex-Ohmeda CS/3 Telemetry SystemDatex-Ohmeda · 2000
- Descendant · cites it directly · 10 of its ownK060135 Mortara Surveyor Telemetry Central StationMortara Instrument, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060135Mortara Surveyor Telemetry Central StationMortara Instrument, Inc. · 2006 · cites it directly10descendants
- K131929Surveyor Central StationMortara Instrument, Inc. · 2013 · 2 generations on6descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 3 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 4 generations on2descendants
- K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000882 | Datex-Ohmeda CS/3 Telemetry System | Datex-Ohmeda | 2000 | — |
| +1 | K060135 | Mortara Surveyor Telemetry Central Station | Mortara Instrument, Inc. | 2006 | — |
| +2 | K131929 | Surveyor Central Station | Mortara Instrument, Inc. | 2013 | — |
| +3 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +4 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +2 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060135 | Mortara Surveyor Telemetry Central Station | 2006 | 10 |
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, K060135 (Mortara Instrument, Inc., 2006) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
https://510kreport.com/device/K000882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000882: Datex-Ohmeda CS/3 Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000882
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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