Cleared Traditional

K870375 - MODEL 617 CARDIAC OUTPUT COMPUTER

K870375 is an FDA 510(k) clearance for MODEL 617 CARDIAC OUTPUT COMPUTER, manufactured by Omnimed B.V.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K870375 · Omnimed B.V. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
138d
Days
Class 2
Risk

K870375 is an FDA 510(k) clearance for the MODEL 617 CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Omnimed B.V. (2596 Bt S-Gravenhage, NL). The FDA issued a Cleared decision on June 16, 1987 after a review of 138 days - within the typical 510(k) review window.

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: 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 Omnimed B.V. devices

FDA 510(k) Submission Details - K870375

510(k) Number K870375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date June 16, 1987
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
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 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K870375.
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
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · Kontron Instruments, Inc. · Feb 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · Datascope Corp. · Jan 1987