Cleared Traditional

K862200 - FORTEC MI-100

K862200 is the FDA 510(k) clearance for FORTEC MI-100 by Fortec Electronic Corp./Nam Tai. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K862200 · Fortec Electronic Corp./Nam Tai · Cardiovascular device
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Nov 1986
Decision
161d
Days
Class 2
Risk

K862200 is an FDA 510(k) clearance for the FORTEC MI-100, BLOOD PRESSURE METER. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Fortec Electronic Corp./Nam Tai (Mississauga, Ont., CA). The FDA issued a Cleared decision on November 18, 1986 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Fortec Electronic Corp./Nam Tai devices

Submission Details

510(k) Number K862200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date November 18, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 32
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K862200.
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720 · A&D Engineering, Inc. · Jul 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · A&D Engineering, Inc. · Jun 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODIFIED CARDIOCAP MONITOR
K862455 · Datex Division Instrumentarium Corp. · Sep 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985