Cleared Traditional

K142693 - ZywieAI Software Library

K142693 is an FDA 510(k) clearance for ZywieAI Software Library, manufactured by Zywie, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K142693 · Zywie, Inc. · Cardiovascular device
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Feb 2015
Decision
151d
Days
Class 2
Risk

K142693 is an FDA 510(k) clearance for the ZywieAI Software Library. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Zywie, Inc. (Johns Creek, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Zywie, Inc. devices

FDA 510(k) Submission Details - K142693

510(k) Number K142693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date February 20, 2015
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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

Ajw Technology Consultants, Inc.
Jon Ward

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 468
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K142693.
Cardio-TriTest
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DIGITAL ELECTROCARDIOGRAPH
K141946 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Feb 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Jan 2015
MAC 800 Resting ECG Analysis System
K142288 · Ge Medical Systems China Co., Ltd. · Dec 2014