Cleared Traditional

K812259 - NIVP MONITOR

K812259 is an FDA 510(k) clearance for NIVP MONITOR, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K812259 · Datascope Corp. · Cardiovascular device
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Sep 1981
Decision
40d
Days
Class 2
Risk

K812259 is an FDA 510(k) clearance for the NIVP MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K812259

510(k) Number K812259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1981
Decision Date September 21, 1981
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
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 1151
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K812259.
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K812936 · Amertek · Dec 1981
SPHYGMOMANOMETER
K812409 · Somatronix Research Corp. · Nov 1981
SPHGOMOMANOMETER
K812059 · Med-Tek Corp. · Aug 1981
TENSIOMETER
K811781 · Vivitek, Inc. · Jul 1981
NORELCO DIGITAL BLOOD PRESSURE METER
K811635 · North American Philips Corp. · Jun 1981
K812259 · NIVP MONITOR
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