Cleared Traditional

K844397 - POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000

K844397 is the FDA 510(k) clearance for POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 by Associated Mills, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K844397 · Associated Mills, Inc. · Cardiovascular device
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Apr 1985
Decision
156d
Days
Class 2
Risk

K844397 is an FDA 510(k) clearance for the POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on April 18, 1985 after a review of 156 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 Associated Mills, Inc. devices

Submission Details

510(k) Number K844397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date April 18, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
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 13
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K844397.
Endophys Blood Pressure Monitor model BPM-30
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K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981