Cleared Traditional

K874338 - TAKEDA MEDICAL BLOOD PRESSURE METER MOD...

K874338 is the FDA 510(k) clearance for TAKEDA MEDICAL BLOOD PRESSURE METER MOD... by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K874338 · A&D Engineering, Inc. · Cardiovascular device
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Feb 1988
Decision
107d
Days
Class 2
Risk

K874338 is an FDA 510(k) clearance for the TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (San Jose, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 107 days - within the typical 510(k) review window.

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 A&D Engineering, Inc. devices

Submission Details

510(k) Number K874338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1987
Decision Date February 05, 1988
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
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 24
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K874338.
MEDILOG OPTIMA
K896535 · Oxford Medilog, Inc. · Jan 1990
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
K884118 · S & W Medico Teknik · Apr 1989
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · Datex Division Instrumentarium Corp. · Jul 1988
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