Cleared Traditional

K811635 - NORELCO DIGITAL BLOOD PRESSURE METER

K811635 is an FDA 510(k) clearance for NORELCO DIGITAL BLOOD PRESSURE METER, manufactured by North American Philips Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K811635 · North American Philips Corp. · Cardiovascular device
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Jun 1981
Decision
20d
Days
Class 2
Risk

K811635 is an FDA 510(k) clearance for the NORELCO DIGITAL BLOOD PRESSURE METER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by North American Philips Corp. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1981 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all North American Philips Corp. devices

FDA 510(k) Submission Details - K811635

510(k) Number K811635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1981
Decision Date June 30, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
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 905
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K811635.
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982
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K813527 · Critikon Company, LLC · Jan 1982
NIVP MONITOR
K812259 · Datascope Corp. · Sep 1981
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · Biochem International, Inc. · Aug 1980
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · Conphar, Inc. · Jun 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · Applied Medical Research · Feb 1980