Cleared Traditional

K844397 - POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000

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

K844397 · Associated Mills, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K844397

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.

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 54
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K844397.
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · Ivy Biomedical Systems, Inc. · Aug 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985
LME BLOOD PRESSURE MONITOR
K832017 · Litton Medical Electronics · Oct 1983
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981