Cleared Traditional

K874378 - DINAMAP VITAL SIGNS MONITOR

K874378 is an FDA 510(k) clearance for DINAMAP VITAL SIGNS MONITOR, 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 65-day FDA review.

K874378 · Critikon Company, LLC · Cardiovascular device
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Dec 1987
Decision
65d
Days
Class 2
Risk

K874378 is an FDA 510(k) clearance for the DINAMAP VITAL SIGNS MONITOR, MODEL 8100T. 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 December 30, 1987 after a review of 65 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.

View all Critikon Company, LLC devices

FDA 510(k) Submission Details - K874378

510(k) Number K874378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1987
Decision Date December 30, 1987
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 K874378.
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · Ivy Biomedical Systems, Inc. · Jul 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K874917 · Oxford Medilog, Inc. · May 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · A&D Engineering, Inc. · Sep 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · Critikon Company, LLC · Jul 1987
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · Draeger Medical, Inc. · Jul 1987