Cleared Traditional

K935020 - OMNI-TRAC MODIFICATION

K935020 is an FDA 510(k) clearance for OMNI-TRAC MODIFICATION, manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K935020 · Invivo Research, Inc. · Cardiovascular device
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Apr 1995
Decision
553d
Days
Class 2
Risk

K935020 is an FDA 510(k) clearance for the OMNI-TRAC MODIFICATION. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Invivo Research, Inc. devices

FDA 510(k) Submission Details - K935020

510(k) Number K935020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date April 26, 1995
Days to Decision 553 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
428d slower than avg
Panel avg: 125d · This submission: 553d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MLD Monitor, St Segment With Alarm

All 13
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K935020.
AS/3 ESTPR MODULE
K953175 · Datex Division Instrumentarium Corp. · Feb 1997
EAGLE 3000/3100 PATIENT MONITOR
K960272 · Marquette Electronics, Inc. · Oct 1996
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
K960934 · Hewlett-Packard Co. · Jun 1996
MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
K920429 · Hewlett-Packard Co. · Jul 1993