Cleared Traditional

K933404 - CRITIKON CENTRAL STATIN MONITOR

K933404 is an FDA 510(k) clearance for CRITIKON CENTRAL STATIN MONITOR, 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 212-day FDA review.

K933404 · Critikon Company, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
212d
Days
Class 2
Risk

K933404 is an FDA 510(k) clearance for the CRITIKON CENTRAL STATIN MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 212 days - an extended review cycle.

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. 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 - K933404

510(k) Number K933404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date February 09, 1994
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
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 K933404.
DATEX AS/3 PATIENT MONITOR
K933156 · Datex Division Instrumentarium Corp. · Dec 1994
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
K935394 · Marquette Electronics, Inc. · Oct 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
THE ACTA FORMULA
K922703 · Biosound, Inc. · Apr 1993
MORTARA INSTRUMENT, INC. E-SCRIBE
K930558 · Mortara Instrument, Inc. · Apr 1993
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
K930134 · S & W Medico Teknik · Apr 1993