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
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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.

View all Dyansys Corp devices

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
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 Peers - DPS Electrocardiograph

All 341
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K072353.
PAGEWRITER CARDIOGRAPH
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MORTARA ELI 10 ELECTROCARDIOGRAPH
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ELI 350 ELECTROCARDIOGRAPH
K062677 · Mortara Instrument, Inc. · Nov 2006