Cleared Traditional

K871418 - VITALNET(TM) SYSTEM (DINAMAP(TM)

K871418 is an FDA 510(k) clearance for VITALNET(TM) SYSTEM (DINAMAP(TM), manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K871418 · Critikon Company, LLC · Cardiovascular device
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Jul 1987
Decision
112d
Days
Class 2
Risk

K871418 is an FDA 510(k) clearance for the VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on July 29, 1987 after a review of 112 days - within the typical 510(k) review window.

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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K871418

510(k) Number K871418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1987
Decision Date July 29, 1987
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K871418.
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · Critikon Company, LLC · Dec 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · A&D Engineering, Inc. · Sep 1987
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · Draeger Medical, Inc. · Jul 1987
SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282
K861374 · Kontron Instruments, Inc. · Jul 1987
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · C.R. Bard, Inc. · Jun 1987