Cleared Traditional

K861856 - NBP 488

K861856 is the FDA 510(k) clearance for NBP 488 by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K861856 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Dec 1986
Decision
222d
Days
Class 2
Risk

K861856 is an FDA 510(k) clearance for the NBP 488, TPR 488. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 222 days - an extended review 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: 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K861856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1986
Decision Date December 22, 1986
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 125d · This submission: 222d
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 528
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861856.
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · Siemens Medical Solutions USA, Inc. · Mar 1987
MODIFIED STBP-680
K863891 · Quinton, Inc. · Feb 1987
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
K861987 · Ohmeda Medical · Feb 1987
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · Physio-Control Corp. · Dec 1986
MODIFIED LIFESTAT 200
K864666 · Physio-Control Corp. · Dec 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · Fukuda Denshi USA, Inc. · Aug 1986