Cleared Traditional

K890198 - PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)

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

K890198 · Paramed Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K890198

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.

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 917
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K890198.
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · A&D Engineering, Inc. · Nov 1989
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · Marquette Electronics, Inc. · Oct 1989
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
MRL BLOOD PRESSURE MONITOR
K885191 · Medical Research Laboratories, Inc. · May 1989
TYPE 9225 NIBP
K890005 · S & W Medico Teknik · May 1989
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K884742 · Medical Data Electronics · Feb 1989