Cleared Traditional

K890005 - TYPE 9225 NIBP

K890005 is the FDA 510(k) clearance for TYPE 9225 NIBP by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K890005 · S & W Medico Teknik · Cardiovascular device
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May 1989
Decision
128d
Days
Class 2
Risk

K890005 is an FDA 510(k) clearance for the TYPE 9225 NIBP. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on May 11, 1989 after a review of 128 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 S & W Medico Teknik devices

Submission Details

510(k) Number K890005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1989
Decision Date May 11, 1989
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
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 356
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K890005.
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · Hewlett-Packard Co. · Feb 1991
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · Marquette Electronics, Inc. · Oct 1989
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · Draeger Medical, Inc. · Jul 1987