Cleared Traditional

K813522 - AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR

K813522 is an FDA 510(k) clearance for AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR, manufactured by Vitar. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K813522 · Vitar · Cardiovascular device
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Apr 1982
Decision
106d
Days
Class 2
Risk

K813522 is an FDA 510(k) clearance for the AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Vitar (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 106 days - within the typical 510(k) review window.

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: 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 Vitar devices

FDA 510(k) Submission Details - K813522

510(k) Number K813522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1981
Decision Date April 01, 1982
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 926
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K813522.
BLOOD PRESSURE MONITORING DEVICES
K822614 · Allied Healthcare Products, Inc. · Sep 1982
AS20 MONITORING SYSTEM
K821614 · Narco Scientific · Jul 1982
NON-INVASIVE AUTOMATIC BLOOD PRESSURE
K821378 · Narco Scientific · Jul 1982
IVAC #1160 MULTIPLE VITAL SIGNS UNIT
K820569 · Y · Mar 1982
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K820135 · Sybron Corp. · Mar 1982
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982