Cleared Traditional

K082718 - TEMPUSIC PATIENT MONITOR

K082718 is an FDA 510(k) clearance for TEMPUSIC 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 23-day FDA review.

K082718 · Remote Diagnostic Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
23d
Days
Class 2
Risk

K082718 is an FDA 510(k) clearance for the TEMPUSIC PATIENT MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Remote Diagnostic Technologies , Ltd. (Basingstoke, Hampshire, GB). The FDA issued a Cleared decision on October 10, 2008 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082718

510(k) Number K082718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2008
Decision Date October 10, 2008
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 234
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