Cleared Traditional

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 (K925899) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925899 · Welch Allyn, Inc. · Cardiovascular device
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May 1993
Decision
182d
Days
Class 2
Risk

K925899 is an FDA 510(k) clearance for the AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on May 21, 1993 after a review of 182 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K925899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1992
Decision Date May 21, 1993
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
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 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K925899.
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MODEL 78553A PRESSURE PLUG-IN MODULE
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K772234 · Hewlett-Packard Co. · Jan 1978
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978