510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K152124Substantially Equivalent

Tempus IC2

Remote Diagnostics Technologies, Ltd., Basingstoke, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152124 is the FDA 510(k) clearance record for Tempus IC2, a class II device, cleared for Remote Diagnostics Technologies, Ltd. on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list one 510(k) clearance for Remote Diagnostics Technologies, Ltd. As of , FDA records show no recalls naming K152124.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Remote Diagnostics Technologies, Ltd. The Old Coach House, The Ave., Farleigh Wallop, Basingstoke, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260