Cleared Abbreviated

K133973 - TEMPUS PRO WITH ENHANCED FEATURES (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K133973 · Remote Diagnostic Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
231d
Days
Class 2
Risk

K133973 is an FDA 510(k) clearance for the TEMPUS PRO WITH ENHANCED FEATURES. Classified as Hospital Cardiac Telemetry (product code QYW), Class II - Special Controls.

Submitted by Remote Diagnostic Technologies , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on August 14, 2014 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Remote Diagnostic Technologies , Ltd. devices

Submission Details

510(k) Number K133973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date August 14, 2014
Days to Decision 231 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code QYW Hospital Cardiac Telemetry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
Definition Devices Are Intended To Continuously Record, Display, And/or Analyze Electrocardiograms Of Patients In In A Healthcare Facility For Detecting Conditions That May Require Prompt Intervention. They May Include Automatic Detection And Recording Of Cardiac Electrical Activity, Automated Detection Of Life-threatening Arrhythmias Or Other Relevant Conditions, And/or Alarm Generation. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Devices Are Intended For Patients Who Require Continuous Monitoring In Hospitals Or Healthcare Facilities, With Onsite Medical Review By Qualified Personnel At The Central Monitoring/analysis Station Followed By Immediate Notification Of Onsite Qualified Medical Responders. Devices May Be Used For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. Devices Are Intended For Prescription Use Only.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.