Cleared Traditional

K854023 - NORELCO ELECTRONIC DIGITAL BP METER HC3501

K854023 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 DXQ) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K854023 · Philips Park · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
177d
Days
Class 2
Risk

K854023 is an FDA 510(k) clearance for the NORELCO ELECTRONIC DIGITAL BP METER HC3501. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Philips Park (Essex, US). The FDA issued a Cleared decision on March 26, 1986 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 K854023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date March 26, 1986
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 78
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K854023.
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · Hewlett-Packard Co. · Jul 1990
C-FLO SUCTION TUBE
K882121 · Concept, Inc. · Jun 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · Kirschner Medical Corp. · Feb 1988
POROCOAT SCHATZKER II ACETABULUM
K852193 · Depuy, Inc. · Jul 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · Howmedica Corp. · Jul 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · Howmedica Corp. · Jul 1985