Cleared Traditional

K890198 - PARAMED MODEL 9350 BLOOD PRESSURE MONIT...

K890198 is the FDA 510(k) clearance for PARAMED MODEL 9350 BLOOD PRESSURE MONIT... by Paramed Technology, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K890198 · Paramed Technology, Inc. · Cardiovascular device
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Jun 1989
Decision
145d
Days
Class 2
Risk

K890198 is an FDA 510(k) clearance for the PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Paramed Technology, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 145 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 Paramed Technology, Inc. devices

Submission Details

510(k) Number K890198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date June 12, 1989
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
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 K890198.
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K890005 · S & W Medico Teknik · May 1989
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K882824 · A&D Engineering, Inc. · Jan 1989
TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
K882825 · A&D Engineering, Inc. · Jan 1989