Cleared Traditional

K855048 - NORELCO DIGITAL BLOOD PRESSURE METER HC3001

K855048 is an FDA 510(k) clearance for NORELCO DIGITAL BLOOD PRESSURE METER HC3001, manufactured by Philips Park. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K855048 · Philips Park · Cardiovascular device
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Nov 1986
Decision
335d
Days
Class 2
Risk

K855048 is an FDA 510(k) clearance for the NORELCO DIGITAL BLOOD PRESSURE METER HC3001. 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 November 17, 1986 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K855048

510(k) Number K855048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date November 17, 1986
Days to Decision 335 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 125d · This submission: 335d
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 918
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K855048.
NBP 488, TPR 488
K861856 · Siemens Medical Solutions USA, Inc. · Dec 1986
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · Physio-Control Corp. · Dec 1986
MODIFIED LIFESTAT 200
K864666 · Physio-Control Corp. · Dec 1986
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · Cas Medical Systems, Inc. · Aug 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · Fukuda Denshi USA, Inc. · Aug 1986
AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
K855127 · Spacelabs, Inc. · Aug 1986