Cleared Traditional

K051126 - CARDIOSCOPE SONOPLUS 3000

K051126 is an FDA 510(k) clearance for CARDIOSCOPE SONOPLUS 3000, manufactured by Pulsonic Ag, Medical Technology. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K051126 · Pulsonic Ag, Medical Technology · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
16d
Days
Class 2
Risk

K051126 is an FDA 510(k) clearance for the CARDIOSCOPE SONOPLUS 3000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Pulsonic Ag, Medical Technology (Alpharetta, US). The FDA issued a Cleared decision on May 19, 2005 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 - K051126

510(k) Number K051126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2005
Decision Date May 19, 2005
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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

Regulatory Technology Services, LLC
MARK JOB

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 - DPS Electrocardiograph

All 535
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K051126.
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K050074 · Welch Allyn, Inc. · Mar 2005
K051126 · CARDIOSCOPE SONOPLUS 3000
Download PDF FDA Summary Pulsonic Ag, Medical …