Cleared Traditional

K041816 - RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

K041816 is an FDA 510(k) clearance for RTX3320PSTN WIRELESS TELEHEALTH GATEWAY, manufactured by Rtx Healthcare A/S. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K041816 · Rtx Healthcare A/S · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
13d
Days
Class 2
Risk

K041816 is an FDA 510(k) clearance for the RTX3320PSTN WIRELESS TELEHEALTH GATEWAY. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Rtx Healthcare A/S (Noerresundby, DK). The FDA issued a Cleared decision on July 19, 2004 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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.

View all Rtx Healthcare A/S devices

FDA 510(k) Submission Details - K041816

510(k) Number K041816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date July 19, 2004
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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

Kema Quality B.V.

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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 178
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K041816.
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NX SYSTEM
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