Cleared Traditional

K854371 - MTC 6210A CARDIAC OUTPUT COMPUTER

K854371 is an FDA 510(k) clearance for MTC 6210A CARDIAC OUTPUT COMPUTER, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 478-day FDA review.

K854371 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
478d
Days
Class 2
Risk

K854371 is an FDA 510(k) clearance for the MTC 6210A CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K854371

510(k) Number K854371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date February 19, 1987
Days to Decision 478 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 125d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K854371.
MX1002 CABLE-CAL TM
K880696 · Medex, Inc. · Jun 1988
HORIZON 9000
K875167 · Mennen Medical, Inc. · May 1988
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · American Edwards Laboratories · Sep 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · Kontron Instruments, Inc. · Feb 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · Datascope Corp. · Jan 1987
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · Gould, Inc. · Aug 1986