# K200849: Tempus LS - Manual

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd. A Philips Company
- Decided: Jul 24, 2020 after 115 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 64 ancestors in all.
No later device cites it as a predicate yet.
5 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140502: Zoll E Series Als, ZOLL Medical Corporation (2014) Summary page 5.
- K021453: Heartstream XL Defibrillator/Monitor, Model #M4735A, Philips Medical Systems (2002) Summary page 5.
- K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring, Philips Medical Systems (2015) Summary page 5.

## Recalls of this device
- Oct 28, 2024 · Class III · Z-0557-2025: 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: 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; 
- May 8, 2023 · Class II · Z-1825-2023: 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 D
- Nov 17, 2020 · Class II · Z-0564-2021: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K200849
Methodology: https://510kreport.com/methodology