Company ยท GB
Remote Diagnostic Technologies Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2020. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
13recalls (1 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 6 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 5 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 3 |
| QYW | Hospital Cardiac Telemetry | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2020 | K201746 | Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited, GB | MHX |
| Jan 10, 2018 | K173768 | Tempus Pro Patient Monitor Remote Diagnostic Technologies , Ltd., GB | MHX |
| Jul 6, 2017 | K170567 | Tempus Pro Patient Monitor Remote Diagnostic Technologies , Ltd., GB | MHX |
| Aug 14, 2014 | K133973 | TEMPUS PRO WITH ENHANCED FEATURES Remote Diagnostic Technologies , Ltd., GB | QYW |
| Aug 12, 2014 | K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) Remote Diagnostic Technologies , Ltd., GB | MWI |
| May 16, 2014 | K133988 | TEMPUS PRO EXTENDED FEATURES Remote Diagnostic Technologies , Ltd., GB | MWI |
| Jun 5, 2013 | K130773 | TEMPUS PRO PATIENT MONITOR Remote Diagnostic Technologies , Ltd., GB | MWI |
| Dec 15, 2011 | K113105 | TEMPUSIC PATIENT MONITOR Remote Diagnostic Technologies , Ltd., GB | MWI |
| May 11, 2010 | K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR Remote Diagnostic Technologies , Ltd., GB | MWI |
| Oct 10, 2008 | K082718 | TEMPUSIC PATIENT MONITOR Remote Diagnostic Technologies , Ltd., GB | DXH |
| Mar 5, 2004 | K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 Remote Diagnostic Technologies , Ltd., GB | DXH |
| May 14, 2001 | K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 Remote Diagnostic Technologies , Ltd., GB | DXH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Remote Diagnostic Technologies Ltd. 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 Open, Classified |
MHX | K201746 |
| Jul 25, 2025 | Remote Diagnostic Technologies Ltd. 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 Open, Classified |
MHX | K201746 |
| May 7, 2025 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R,
00-1026-R, 00-1004, 00-1007 Open, Classified |
MHX | K201746 |
| Apr 24, 2025 | Remote Diagnostic Technologies Ltd. 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) Open, Classified |
MHX | K130773 K201746 |
| Nov 26, 2024 | Remote Diagnostic Technologies Ltd. Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode Open, Classified |
LDD | K200849 |
| Jun 6, 2024 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual Open, Classified |
LDD | K200849 |
| Sep 21, 2023 | Remote Diagnostic Technologies Ltd. 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 Open, Classified |
MHX | K201746 |
| Jun 12, 2023 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Open, Classified |
LDD | K200849 |
| Apr 1, 2023 | Remote Diagnostic Technologies Ltd. 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 Open, Classified |
MHX | K201746 |
| Jan 28, 2022 | Remote Diagnostic Technologies Ltd. Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 Terminated |
LDD | None listed |
| May 25, 2021 | Remote Diagnostic Technologies Ltd. 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 t Open, Classified |
MHX | K201746 |
| Dec 11, 2020 | Remote Diagnostic Technologies Ltd. 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 Terminated |
LDD | K200849 |
| May 11, 2011 | Remote Diagnostic Technologies Ltd. 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 mo Terminated |
MWI | K101264 |