Cleared Traditional

K852574 - WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C

K852574 is an FDA 510(k) clearance for WELCH ALLYN MODEL 40000 SPHYG W/ 40030-..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K852574 · Welch Allyn, Inc. · Cardiovascular device
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Mar 1986
Decision
268d
Days
Class 2
Risk

K852574 is an FDA 510(k) clearance for the WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 268 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

FDA 510(k) Submission Details - K852574

510(k) Number K852574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date March 13, 1986
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 1208
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K852574.
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LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI
K853599 · Litton Datamedix · Mar 1986
SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR
K852421 · Nbs Medical, Inc. · Feb 1986
COMFORT - CUF
K852978 · Dynasty Instruments, Ltd. · Jan 1986
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
K852457 · Healthteam · Dec 1985
K852574 · WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
Download PDF Welch Allyn, Inc.