Cleared Traditional

K822055 - CNIBP BLOOD PRESSURE MEASUREMENT SYS

K822055 is the FDA 510(k) clearance for CNIBP BLOOD PRESSURE MEASUREMENT SYS by Ohio Medical Products. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K822055 · Ohio Medical Products · Cardiovascular device
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Nov 1982
Decision
111d
Days
Class 2
Risk

K822055 is an FDA 510(k) clearance for the CNIBP BLOOD PRESSURE MEASUREMENT SYS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ohio Medical Products (Walker, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 111 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 Ohio Medical Products devices

Submission Details

510(k) Number K822055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1982
Decision Date November 01, 1982
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
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 389
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K822055.
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983
IVAC #1160 MULTIPLE VITAL SIGNS UNIT
K820569 · Y · Mar 1982
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982
NIVP MONITOR
K812259 · Datascope Corp. · Sep 1981