Cleared Traditional

K880079 - TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420

K880079 is an FDA 510(k) clearance for TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS...., manufactured by A&D Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K880079 · A&D Engineering, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
80d
Days
Class 2
Risk

K880079 is an FDA 510(k) clearance for the TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420. 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 March 31, 1988 after a review of 80 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 A&D Engineering, Inc. devices

FDA 510(k) Submission Details - K880079

510(k) Number K880079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1988
Decision Date March 31, 1988
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K880079.
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
K893232 · Camino Laboratories, Inc. · Jul 1989
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
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