Data / Medical devices / United Kingdom / Remote Diagnostic Technologies Ltd.
Remote Diagnostic Technologies Ltd.: FDA-registered device maker in FARNBOROUGH Hampshire, United Kingdom, 8 510(k) clearances
Remote Diagnostic Technologies Ltd. is registered with the FDA (registration 3003832357) in FARNBOROUGH Hampshire, United Kingdom. It lists 19 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 18, 2020. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003832357
- Address
- Ascent 1, Farnborough Aerospace Centre Aerospace Boulevard, FARNBOROUGH Hampshire, United Kingdom, GU14 6XW
- Owner or operator
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD. (9044740)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 11, 2013
- Registered through
- 2026
- Brand names listed
- TEMPUS LS-MANUAL, Tempus PRO Accessories (Ultrasound & Video Laryngoscope probe), Tempus PRO With Enhanced Features, Tempus PRO extended features, Tempus Pro, Tempus Pro Patient Monitor Model numbers 00-1,00-1005,00-1006,00-1007
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2020 | K201746 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | Remote Diagnostic Technologies Limited | accessdata.fda.gov |
| July 24, 2020 | K200849 | Tempus LS - Manual | LDD | Substantially Equivalent | Remote Diagnostic Technologies, Ltd. A Philips Company | accessdata.fda.gov |
| January 10, 2018 | K173768 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| July 6, 2017 | K170567 | Tempus Pro Patient Monitor | MHX | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| August 14, 2014 | K133973 | TEMPUS PRO WITH ENHANCED FEATURES | QYW | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| August 12, 2014 | K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | MWI | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| May 16, 2014 | K133988 | TEMPUS PRO EXTENDED FEATURES | MWI | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
| June 5, 2013 | K130773 | TEMPUS PRO PATIENT MONITOR | MWI | Substantially Equivalent | Remote Diagnostic Technologies , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 26, 2025 | 97889 | Class II | Ongoing | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual | Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions. | accessdata.fda.gov |
| May 30, 2025 | 97197 | Class II | Ongoing | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R | Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system | accessdata.fda.gov |
| April 16, 2025 | 96678 | Class II | Ongoing | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus P | software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. | accessdata.fda.gov |
| April 15, 2025 | 96719 | Class II | Ongoing | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 | Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce i | accessdata.fda.gov |
| October 28, 2024 | 95642 | Class III | Ongoing | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. | accessdata.fda.gov |
| May 9, 2024 | 94618 | Class II | Ongoing | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse. | accessdata.fda.gov |
| August 24, 2023 | 92914 | Class II | Ongoing | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 | Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; ma | accessdata.fda.gov |
| May 8, 2023 | 92251 | Class II | Ongoing | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM". | accessdata.fda.gov |
| February 23, 2023 | 91805 | Class II | Ongoing | Tempus Pro Patient Monitor 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 an | During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. | accessdata.fda.gov |
| January 28, 2022 | 89595 | Class II | Terminated | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | accessdata.fda.gov |
| May 25, 2021 | 88051 | Class II | Ongoing | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (t | The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. | accessdata.fda.gov |
| November 17, 2020 | 86801 | Class II | Terminated | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applicatio | A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device | accessdata.fda.gov |
| March 25, 2011 | 58479 | Not yet classified | Terminated | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead E | It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Ventilatory Effort Recorder
- All makers of Oximeter
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
Updated January 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.