Cleared Traditional

K854023 - NORELCO ELECTRONIC DIGITAL BP METER HC3501

K854023 is an FDA 510(k) clearance for NORELCO ELECTRONIC DIGITAL BP METER HC3501, manufactured by Philips Park. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K854023

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.

DXQ Device Classification - Class 2, Special Controls

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 149
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K854023.
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421 · Pymah Corp. · Jan 1989
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