Cleared Traditional

K172068 - Kenz Cardico1211

K172068 is an FDA 510(k) clearance for Kenz Cardico1211, 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 329-day FDA review.

K172068 · Suzuken Co., Ltd. · Cardiovascular device
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Jun 2018
Decision
329d
Days
Class 2
Risk

K172068 is an FDA 510(k) clearance for the Kenz Cardico1211. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Suzuken Co., Ltd. (Nagoya, JP). The FDA issued a Cleared decision on June 1, 2018 after a review of 329 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 Suzuken Co., Ltd. devices

FDA 510(k) Submission Details - K172068

510(k) Number K172068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2017
Decision Date June 01, 2018
Days to Decision 329 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
204d slower than avg
Panel avg: 125d · This submission: 329d
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

Z&B Enterprises, Inc.
Rhona Shanker

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 303
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K172068.
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