Cleared Traditional

K914273 - A&D TM-2421/2021 AMBULATORY BLOOD PRESS...

K914273 is the FDA 510(k) clearance for A&D TM-2421/2021 AMBULATORY BLOOD PRESS... by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 504-day FDA review.

K914273 · A&D Engineering, Inc. · Cardiovascular device
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Feb 1993
Decision
504d
Days
Class 2
Risk

K914273 is an FDA 510(k) clearance for the A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (Milpitas, US). The FDA issued a Cleared decision on February 9, 1993 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all A&D Engineering, Inc. devices

Submission Details

510(k) Number K914273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1991
Decision Date February 09, 1993
Days to Decision 504 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
379d slower than avg
Panel avg: 125d · This submission: 504d
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 30
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