Cleared Traditional

K943709 - DINAMAP PLUS VITAL SIGNS MONOITOR

K943709 is an FDA 510(k) clearance for DINAMAP PLUS VITAL SIGNS MONOITOR, manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K943709 · Critikon Company, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
319d
Days
Class 2
Risk

K943709 is an FDA 510(k) clearance for the DINAMAP PLUS VITAL SIGNS MONOITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on June 16, 1995 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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. Elevated predicate reliance profile. 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 - K943709

510(k) Number K943709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date June 16, 1995
Days to Decision 319 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 125d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 282
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K943709.
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K952173 · Hewlett-Packard Co. · Aug 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · Quinton, Inc. · Jun 1995
HEART RATE VARIABILITY SOFTWARE OPTION
K950779 · Spacelabs, Inc. · Apr 1995
DATEX AS/3 PATIENT MONITOR
K933156 · Datex Division Instrumentarium Corp. · Dec 1994
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
K935394 · Marquette Electronics, Inc. · Oct 1994