Cleared Traditional

K992425 - TES-20

K992425 is an FDA 510(k) clearance for TES-20, manufactured by Tes Electrical Electronic Corp.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K992425 · Tes Electrical Electronic Corp. · Cardiovascular device
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Oct 1999
Decision
90d
Days
Class 2
Risk

K992425 is an FDA 510(k) clearance for the TES-20. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Tes Electrical Electronic Corp. (Taipei, Taiwan 300, CN). The FDA issued a Cleared decision on October 19, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Tes Electrical Electronic Corp. devices

FDA 510(k) Submission Details - K992425

510(k) Number K992425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1999
Decision Date October 19, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 27
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K992425.
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