Cleared Traditional

K033410 - TEMPUS 2000 PATIENT MONITOR

K033410 is an FDA 510(k) clearance for TEMPUS 2000 PATIENT MONITOR, manufactured by Remote Diagnostic Technologies , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K033410 · Remote Diagnostic Technologies , Ltd. · Cardiovascular device
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Mar 2004
Decision
130d
Days
Class 2
Risk

K033410 is an FDA 510(k) clearance for the TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Remote Diagnostic Technologies , Ltd. (Hampshire, GB). The FDA issued a Cleared decision on March 5, 2004 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Remote Diagnostic Technologies , Ltd. devices

FDA 510(k) Submission Details - K033410

510(k) Number K033410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date March 05, 2004
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 123
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K033410.
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