Cleared Traditional

K873765 - FORTEC MI-100

K873765 is the FDA 510(k) clearance for FORTEC MI-100 by Nam Tai , Ltd.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K873765 · Nam Tai , Ltd. · Cardiovascular device
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Oct 1987
Decision
23d
Days
Class 2
Risk

K873765 is an FDA 510(k) clearance for the FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Nam Tai , Ltd. (Kowloon, Hong Kong, HK). The FDA issued a Cleared decision on October 9, 1987 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nam Tai , Ltd. devices

Submission Details

510(k) Number K873765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1987
Decision Date October 09, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 K873765.
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · A&D Engineering, Inc. · Mar 1988
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
K874338 · A&D Engineering, Inc. · Feb 1988
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620
K874339 · A&D Engineering, Inc. · Dec 1987
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