Cleared Traditional

K936051 - OMNI-CENTRAL STATION MONITOR

K936051 is an FDA 510(k) clearance for OMNI-CENTRAL STATION MONITOR, manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K936051 · Invivo Research, Inc. · Cardiovascular device
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Jul 1994
Decision
198d
Days
Class 2
Risk

K936051 is an FDA 510(k) clearance for the OMNI-CENTRAL STATION MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

FDA 510(k) Submission Details - K936051

510(k) Number K936051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date July 06, 1994
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 249
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K936051.
K3 SYSTEM
K934644 · Astro-Med, Inc. · Nov 1994
PAM CARDIAC MONITOR
K934684 · Technology Transfer, Inc. · Oct 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257 · Bio-Tek Instruments, Inc. · Sep 1994
520 DISPLAY DRIVER- STATUS I
K926298 · Vidco, Inc. · May 1994
MEDSIM 300 PATIENT SIMULATOR
K935817 · Dynatech/Nevada, Inc. · Jan 1994
ESCORT 100/300 SERIES B PATIENT MONITORS
K930004 · Medical Data Electronics · Jun 1993
K936051 · OMNI-CENTRAL STATION MONITOR
Download PDF Invivo Research, Inc.