Cleared Traditional

K852128 - NORELCO ELECTRONIC DIGITAL BP METER HC3501

K852128 is the FDA 510(k) clearance for NORELCO ELECTRONIC DIGITAL BP METER HC3501 by Philips Park. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K852128 · Philips Park · Cardiovascular device
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Sep 1985
Decision
120d
Days
Class 2
Risk

K852128 is an FDA 510(k) clearance for the NORELCO ELECTRONIC DIGITAL BP METER HC3501. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Philips Park (Essex, US). The FDA issued a Cleared decision on September 12, 1985 after a review of 120 days - within the typical 510(k) review window.

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.

View all Philips Park devices

Submission Details

510(k) Number K852128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date September 12, 1985
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 537
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K852128.
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