Cleared Traditional

K062304 - DLM112 DAYLINK MONITOR

K062304 is an FDA 510(k) clearance for DLM112 DAYLINK MONITOR, 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 52-day FDA review.

K062304 · Rtx Healthcare A/S · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
52d
Days
Class 2
Risk

K062304 is an FDA 510(k) clearance for the DLM112 DAYLINK MONITOR. 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 September 29, 2006 after a review of 52 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 - K062304

510(k) Number K062304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2006
Decision Date September 29, 2006
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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.
ELIZABETH A ROSENFELD

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
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