Cleared Traditional

K865010 - MICOR

K865010 is the FDA 510(k) clearance for MICOR by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K865010 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Jul 1987
Decision
195d
Days
Class 2
Risk

K865010 is an FDA 510(k) clearance for the MICOR. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on July 6, 1987 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K865010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date July 06, 1987
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 251
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K865010.
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · Hewlett-Packard Co. · Jan 1991
Q5000 PC WORKSTATION
K892113 · Quinton, Inc. · May 1989
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988
QUINTON Q.CATH
K862740 · Quinton, Inc. · Oct 1986
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · Marquette Electronics, Inc. · Feb 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985