Cleared Traditional

K833753 - AC ADAPTERS FOR BLOOD PRESSURE METERS

K833753 is the FDA 510(k) clearance for AC ADAPTERS FOR BLOOD PRESSURE METERS by Philips Park. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K833753 · Philips Park · Cardiovascular device
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Jan 1984
Decision
83d
Days
Class 2
Risk

K833753 is an FDA 510(k) clearance for the AC ADAPTERS FOR BLOOD PRESSURE METERS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Philips Park (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 83 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 Philips Park devices

Submission Details

510(k) Number K833753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1983
Decision Date January 30, 1984
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 537
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K833753.
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI
K840469 · Sybron Corp. · May 1984
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · Critikon Company, LLC · Nov 1983
ACCU-SPHYG
K832060 · Olympic Medical Corp. · Oct 1983