Cleared Traditional

K894945 - NON-INVASIVE BLOOD PRESSURE MODULE

K894945 is the FDA 510(k) clearance for NON-INVASIVE BLOOD PRESSURE MODULE by Marquette Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894945 · Marquette Electronics, Inc. · Cardiovascular device
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Oct 1989
Decision
84d
Days
Class 2
Risk

K894945 is an FDA 510(k) clearance for the NON-INVASIVE BLOOD PRESSURE MODULE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 26, 1989 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K894945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date October 26, 1989
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 551
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K894945.
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · Kontron Instruments, Inc. · Jan 1990
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
K895428 · A&D Engineering, Inc. · Nov 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · A&D Engineering, Inc. · Nov 1989
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
TYPE 9225 NIBP
K890005 · S & W Medico Teknik · May 1989
TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
K882824 · A&D Engineering, Inc. · Jan 1989