Cleared Traditional

SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 (K861374) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861374 · Kontron Instruments, Inc. · Cardiovascular device
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Jul 1987
Decision
466d
Days
Class 2
Risk

K861374 is an FDA 510(k) clearance for the SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 466 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Kontron Instruments, Inc. devices

Submission Details

510(k) Number K861374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date July 21, 1987
Days to Decision 466 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
341d slower than avg
Panel avg: 125d · This submission: 466d
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 246
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861374.
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
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AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · C.R. Bard, Inc. · Jun 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · Quinton, Inc. · Jun 1987
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · Siemens Medical Solutions USA, Inc. · Mar 1987