Cleared Traditional

K072353 - PORTABLE ECSCOPE

K072353 is an FDA 510(k) clearance for PORTABLE ECSCOPE, manufactured by Dyansys Corp. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K072353 · Dyansys Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
8d
Days
Class 2
Risk

K072353 is an FDA 510(k) clearance for the PORTABLE ECSCOPE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dyansys Corp (Burlingame, US). The FDA issued a Cleared decision on August 30, 2007 after a review of 8 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 - K072353

510(k) Number K072353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date August 30, 2007
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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

Underwriters Laboratories, Inc.
NED DEVINE

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 K072353.
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · Welch Allyn, Inc. · Nov 2007
THE PORTABLE ANSISCOPE
K071168 · Dyansys, Inc. · Aug 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · Nihon Kohden America, Inc. · Aug 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · Nihon Kohden America, Inc. · Aug 2007
PALM ECG RECORDER, MODEL EP-201/202
K061123 · Parama-Tech Company., Ltd. · Jun 2007
CORSCREEN
K070614 · Viasys Healthcare GmbH · May 2007
K072353 · PORTABLE ECSCOPE
Download PDF FDA Summary Dyansys Corp