Cleared Traditional

K222902 - Electrocardiograph: SE-1200 Pro and SE-1201 Pro (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222902 · Edan Instruments, Inc. · Cardiovascular device

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Jul 2023

Decision

308d

Days

Class 2

Risk

K222902 is an FDA 510(k) clearance for the Electrocardiograph: SE-1200 Pro and SE-1201 Pro. 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 28, 2023 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number	K222902 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 2022
Decision Date	July 28, 2023
Days to Decision	308 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

183d slower than avg

Panel avg: 125d · This submission: 308d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.