Cleared Traditional

K881155 - MODEL BPS08 BLOOD PRESSURE MODULE

K881155 is an FDA 510(k) clearance for MODEL BPS08 BLOOD PRESSURE MODULE, manufactured by Fresenius USA, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K881155

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
Combination Product No
PCCP Authorized No
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.

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 621
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K881155.
CARDIOCAP(TM) CM-104 MONITOR
K884955 · Datex Division Instrumentarium Corp. · Dec 1988
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
K882635 · Nihon Seimitsu Sokki Co., Ltd. · Nov 1988
POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · Ivy Biomedical Systems, Inc. · Jul 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K874917 · Oxford Medilog, Inc. · May 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988