Cleared Traditional

K830682 - CARDIVAN BLOOD PRESSURE MONITOR

K830682 is the FDA 510(k) clearance for CARDIVAN BLOOD PRESSURE MONITOR by Paramed Technology, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K830682 · Paramed Technology, Inc. · Cardiovascular device
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Aug 1983
Decision
174d
Days
Class 2
Risk

K830682 is an FDA 510(k) clearance for the CARDIVAN BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Paramed Technology, Inc.. The FDA issued a Cleared decision on August 11, 1983 after a review of 174 days - an extended review 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: 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 Paramed Technology, Inc. devices

Submission Details

510(k) Number K830682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1983
Decision Date August 11, 1983
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
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 544
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K830682.
NARCOTRACE 80
K830338 · Narco Scientific · Dec 1983
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · Critikon Company, LLC · Nov 1983
ACCU-SPHYG
K832060 · Olympic Medical Corp. · Oct 1983
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · Critikon Company, LLC · Jun 1983
CNIBP BLOOD PRESSURE MEASUREMENT SYS
K822055 · Ohio Medical Products · Nov 1982