510(k) · Cleared
Recalled · Class II · 2024Tempus LS - Manual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remote Diagnostic Technologies, Ltd. A Philips Company · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Jul 24, 2020 as substantially equivalent to K140502 (ZOLL Medical Corporation, 2014) and 2 other predicates after a 115-day review. Its family tree reaches back 13 generations to 1997. 5 of the 65 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times.
- Decided
- Jul 24, 2020
- Review
- 115 days
- Class
- Class II
- Product code
- LDD
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 13 generations to K962603 (1997). 64 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet. 5 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- 1 generation backK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- This deviceK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 6 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 5 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 4 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- 1 generation backK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- This deviceK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −6 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −4 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −2 | K130153 | Hearstart MRX with Airway Confimration Assist | Philips Medical Systems | 2013 | — |
| −1 | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | Philips Medical Systems | 2015 | — |
| 0 (this device) | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 1 |
| 2003 | 3 | 1 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2006 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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.
5 devices in this family have a Class I recall. 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 LDD device
- #1 K203231 Switched Internal Paddlesscore 1.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K140502 | Zoll E Series AlsSummary page 5…es: DRO, LIX, DPS Regulation Number: 21 CFR 870. 5300 Predicate Device(s) Primary Predicate: ZOLL E-Series ALS (K140502) Secondary Predicate: Philips HeartStart XL (K021453) Philips HeartStar… | 2014 |
| * | K021453 | Heartstream XL Defibrillator/Monitor, Model #M4735ASummary page 5…R 870. 5300 Predicate Device(s) Primary Predicate: ZOLL E-Series ALS (K140502) Secondary Predicate: Philips HeartStart XL (K021453) Philips HeartStart XL+ (K133659) Device Description The TEMPUS LS – MANUAL is a compac… | 2002 |
| * | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringSummary page 5…ZOLL E-Series ALS (K140502) Secondary Predicate: Philips HeartStart XL (K021453) Philips HeartStart XL+ (K133659) Device Description The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct cu… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2024 | Class III | Z-0557-2025 | Labeling Change Control | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| May 9, 2024 | Class II | Z-2028-2024 | Labeling design | 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… |
| May 8, 2023 | Class II | Z-1825-2023 | Device Design | 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". |
| Nov 17, 2020 | Class II | Z-0564-2021 | Software design | 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… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 12 Class I recalls
- K051134Heartstart MRX with Q-CPR Option, Models M3535A or M3536APhilips Medical Systems · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
- K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 64 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, 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 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TEMPUS LS - MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support. Manual Defibrillation In Manual Defibrillation mode, the…
Read the full statement (438 words)
The TEMPUS LS - MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.
Manual Defibrillation
In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
• Unconsciousness
• Absence of breathing, and
• Absence of pulse.
This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia.
Defibrillation is indicated for adult and pediatric patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device’s pediatric mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient’s exact age or weight.
Cardioversion
The TEMPUS LS – MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient’s ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.
External Pacing
The TEMPUS LS – MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include:
• Resuscitation from standstill or bradycardia of any etiology.
• As a standby when standstill or bradycardia might be expected.
External pacing is indicated for adult and pediatric patients.
ECG Display
The TEMPUS LS – MANUAL is intended to display a patient’s ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric patients for attended monitoring of the patient’s ECG signal (e.g., before starting demand pacing or after successful defibrillation).
CPR Feedback
The TEMPUS LS – MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs.
CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200849 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200849: Tempus LS - Manual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200849
Report an extraction error
Are you the manufacturer?
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