Cleared Traditional

K861987 - 2120 NON-INVASIVE BLOOD PRESSURE MONITO...

K861987 is the FDA 510(k) clearance for 2120 NON-INVASIVE BLOOD PRESSURE MONITO... by Ohmeda Medical. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K861987 · Ohmeda Medical · Cardiovascular device
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Feb 1987
Decision
257d
Days
Class 2
Risk

K861987 is an FDA 510(k) clearance for the 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ohmeda Medical (Englewood, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 257 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.

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Submission Details

510(k) Number K861987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1986
Decision Date February 03, 1987
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
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 514
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861987.
MODIFIED DRAGER SPHYGMOMED
K862427 · Draeger Medical, Inc. · Mar 1987
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
NBP 488, TPR 488
K861856 · Siemens Medical Solutions USA, Inc. · Dec 1986
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · Physio-Control Corp. · Dec 1986
MODIFIED LIFESTAT 200
K864666 · Physio-Control Corp. · Dec 1986