Cleared Traditional

K920778 - OMRON WRIST DIGITAL BLOOD PRESSURE MONI...

K920778 is the FDA 510(k) clearance for OMRON WRIST DIGITAL BLOOD PRESSURE MONI... by Omron Healthcare, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K920778 · Omron Healthcare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
308d
Days
Class 2
Risk

K920778 is an FDA 510(k) clearance for the OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on December 24, 1992 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Omron Healthcare, Inc. devices

Submission Details

510(k) Number K920778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date December 24, 1992
Days to Decision 308 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 125d · This submission: 308d
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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K920778.
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994
CRITIKON VITAL SIGNS MODULE
K915697 · Critikon Company, LLC · Jul 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · Omron Healthcare, Inc. · May 1993
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · Omron Healthcare, Inc. · Dec 1992
NIBP 9225 COMBI
K912815 · S & W Medico Teknik · Oct 1992
BP PUMP
K921074 · Bio-Tek Instruments, Inc. · Oct 1992