Tempus LS - Manual

510(k) K200849

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK200849	Date24 Jul 2020Cleared	StatusActive

4 recalls · 3 ongoing · FDA

- Ongoing Z-0557-2025 FDA Class III initiated 28 Oct 2024
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
- Ongoing Z-2028-2024 FDA Class II initiated 9 May 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; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
- Ongoing Z-1825-2023 FDA Class II initiated 8 May 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 DPM".
- Terminated Z-0564-2021 FDA Class II initiated 17 Nov 2020
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 is still able to deliver a manual defibrillation shock.

1 jurisdiction

United States — FDA 510(k) Active

510(k)