Cleared Traditional

K811949 - KENL-ECG-3

K811949 is an FDA 510(k) clearance for KENL-ECG-3, manufactured by Suzuken Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K811949 · Suzuken Co., Ltd. · Cardiovascular device
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Aug 1981
Decision
37d
Days
Class 2
Risk

K811949 is an FDA 510(k) clearance for the KENL-ECG-3. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Suzuken Co., Ltd. (Walker, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 37 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 Suzuken Co., Ltd. devices

FDA 510(k) Submission Details - K811949

510(k) Number K811949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1981
Decision Date August 13, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
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 Peers - DPS Electrocardiograph

All 332
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K811949.
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
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PHYSIOLOGIC RECORDER
K810696 · Honeywell, Inc. · Mar 1981
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
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STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981