Cleared Traditional

K080036 - PORTABLE ECSCOPE 12I

K080036 is an FDA 510(k) clearance for PORTABLE ECSCOPE 12I, manufactured by Dyansys, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K080036 · Dyansys, Inc. · Cardiovascular device
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Jan 2008
Decision
9d
Days
Class 2
Risk

K080036 is an FDA 510(k) clearance for the PORTABLE ECSCOPE 12I. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dyansys, Inc. (Burlingame, US). The FDA issued a Cleared decision on January 16, 2008 after a review of 9 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, Inc. devices

FDA 510(k) Submission Details - K080036

510(k) Number K080036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2008
Decision Date January 16, 2008
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K080036.
PAGEWRITER CARDIOGRAPH
K080999 · Philips Medical Systems · May 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · Medtechs, LLC · Apr 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · Ge Healthcare Systems Information Technologies · Jan 2008
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