510(k) · Cleared
ClearedTempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)
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 Aug 12, 2014 as substantially equivalent to K130773 (Remote Diagnostic Technologies, Ltd., 2013) and 2 other predicates after a 225-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 12, 2014
- Review
- 225 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K935595 (1995). 98 ancestors in all, the oldest K850478 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK134014 Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK173768 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK201746 Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · Recalled
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 1 generation backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- This deviceK134014 Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · cites it directly2descendants
- K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2018 · 2 generations on1descendant
- K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −1 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| 0 (this device) | K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe) | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +1 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +2 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | — |
| +3 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 12 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 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 |
|---|---|---|---|
| * | K130773 | Tempus Pro Patient MonitorSummary page 5…tial Equivalence The predicate for the Tempus Pro Patient Monitor with the specified accessories attached is the cleared Tempus Pro Patient Monitor (K130773). The Predicate for the optional Ultrasound features are: • K070907 – Interson USB ultrasound probe syste… | 2013 |
| * | K070907 | Interson Usb Ultrasound Probe SystemSummary page 5…ied accessories attached is the cleared Tempus Pro Patient Monitor (K130773). The Predicate for the optional Ultrasound features are: • K070907 – Interson USB ultrasound probe system • K102153 – MobiUS Ultrasound imaging system As the accessories ar… | 2007 |
| * | K102153 | Mobius Ultrasound Imaging SystemSummary page 5…atient Monitor (K130773). The Predicate for the optional Ultrasound features are: • K070907 – Interson USB ultrasound probe system • K102153 – MobiUS Ultrasound imaging system As the accessories are unmodified, claims for substantial equivalence relate to the… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170567 | Tempus Pro Patient Monitor | 2017 | 2 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 98 ancestors have a recall of any class.
- Of its descendants, K170567 (Remote Diagnostic Technologies, Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K130773.
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. 2014, 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?
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact…
Read the full statement (156 words)
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134014: Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134014
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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