Cleared Traditional

K842486 - ELECTRONIC DIGITAL BP METER HC 3001

K842486 is an FDA 510(k) clearance for ELECTRONIC DIGITAL BP METER HC 3001, 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 59-day FDA review.

K842486 · North American Philips Corp. · Cardiovascular device
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Aug 1984
Decision
59d
Days
Class 2
Risk

K842486 is an FDA 510(k) clearance for the ELECTRONIC DIGITAL BP METER HC 3001. 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 August 24, 1984 after a review of 59 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 - K842486

510(k) Number K842486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date August 24, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 K842486.
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