Cleared Traditional

MODEL BPS08 BLOOD PRESSURE MODULE (K881155) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881155 · Fresenius USA, Inc. · Cardiovascular device
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Jul 1988
Decision
132d
Days
Class 2
Risk

K881155 is an FDA 510(k) clearance for the MODEL BPS08 BLOOD PRESSURE MODULE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 132 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 Fresenius USA, Inc. devices

Submission Details

510(k) Number K881155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date July 28, 1988
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
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 286
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K881155.
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · Hewlett-Packard Co. · Feb 1991
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
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · C.R. Bard, Inc. · Jun 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · Quinton, Inc. · Jun 1987