Cleared Traditional

K955045 - OMNI-TRAK PATIENT MONITORING SYSTEM

K955045 is an FDA 510(k) clearance for OMNI-TRAK PATIENT MONITORING SYSTEM, manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K955045 · Invivo Research, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
251d
Days
Class 2
Risk

K955045 is an FDA 510(k) clearance for the OMNI-TRAK PATIENT MONITORING SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on July 11, 1996 after a review of 251 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 Invivo Research, Inc. devices

FDA 510(k) Submission Details - K955045

510(k) Number K955045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1995
Decision Date July 11, 1996
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
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 334
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K955045.
PATIENT MONITOR MODEL 405P
K955546 · Ivy Biomedical Systems, Inc. · Aug 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · Johnson & Johnson Medical, Inc. · Aug 1996
CARDIMAX MODEL FX-2111
K955416 · Fukuda Denshi USA, Inc. · Jul 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
K950018 · Cambridge Heart, Inc. · Feb 1996
6200 VITAL SIGNS MONITOR
K953415 · Bci Intl., Inc. · Oct 1995