Cleared Traditional

K822055 - CNIBP BLOOD PRESSURE MEASUREMENT SYS

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

K822055 · Ohio Medical Products · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K822055

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
Combination Product No
PCCP Authorized No
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.

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 660
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K822055.
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
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