Cleared Traditional

CARDIOSCOPE SONOPLUS 3000 (K051126) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051126 · Pulsonic Ag, Medical Technology · Cardiovascular device
Download Printable Device Report (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.

View all Pulsonic Ag, Medical Technology devices

Submission Details

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
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.

Device Classification

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 Peers - DPS Electrocardiograph

All 81
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K051126.
Electrocardiograph
K171943 · Edan Instruments, Inc. · Sep 2017
Electrocardiograph
K170995 · Edan Instruments, Inc. · Jun 2017
PC ECG
K160876 · Edan Instruments, Inc. · Feb 2017
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
HP CATHSTATION - MODEL M1264B
K961401 · Hewlett-Packard Co. · Oct 1996