Cleared Traditional

K161302 - PC ECG

K161302 is an FDA 510(k) clearance for PC ECG, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K161302 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
53d
Days
Class 2
Risk

K161302 is an FDA 510(k) clearance for the PC ECG. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2016 after a review of 53 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 - K161302

510(k) Number K161302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date July 01, 2016
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Edan Medical
DOUG WORTH

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 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K161302.
CARDIOLINE touchECG
K160746 · Cardioline S.P.A · Nov 2016
ECG100+, ECG200+
K160840 · Cardioline S.P.A · Aug 2016
Quantitative Electrocardiographic Detector (QED 2000)
K152135 · Acme Portable Machines, Inc. · Aug 2016
Portable ECG Monitor
K152863 · Contec Medical Systems Co.,Ltd · Jun 2016
Diagnostic Station DS20
K152043 · Schiller AG · May 2016
MODEL 621/624 BIOMAGNETOMETER
K151135 · Tristan Technologies, Inc. · Mar 2016