Cleared Traditional

K861856 - NBP 488, TPR 488

K861856 is an FDA 510(k) clearance for NBP 488, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K861856

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.

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 858
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
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · Cas Medical Systems, Inc. · Aug 1986