Cleared Traditional

KENZ-CARDICO 1201 (K870443) - FDA 510(k) Clearance

K870443 · Suzuken Co., Ltd. · Cardiovascular device
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Jul 1987
Decision
148d
Days
-
Risk

K870443 is an FDA 510(k) clearance for the KENZ-CARDICO 1201.

Submitted by Suzuken Co., Ltd. (Culver City, US). The FDA issued a Cleared decision on July 1, 1987 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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 Suzuken Co., Ltd. devices

Submission Details

510(k) Number K870443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date July 01, 1987
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 16
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K870443.
CARDIOFAX Q ECG-8420A
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PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · Hewlett-Packard Co. · Jul 1990
Q750 ELECTROCARDIOGRAPH
K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987
N-CHANNEL
K834212 · Philips Medical Systems (Cleveland), Inc. · Nov 1984