Cleared Traditional

K960861 - OMICRON MONITOR

K960861 is the FDA 510(k) clearance for OMICRON MONITOR by Core-M, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K960861 · Core-M, Inc. · Anesthesiology device
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Aug 1996
Decision
171d
Days
Class 2
Risk

K960861 is an FDA 510(k) clearance for the OMICRON MONITOR, DELTA MONITOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Core-M, Inc. (Allston, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 171 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Core-M, Inc. devices

Submission Details

510(k) Number K960861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 01, 1996
Decision Date August 19, 1996
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 140d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 120
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K960861.
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K970460 · Puritan Bennett Corp. · Apr 1998
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · Puritan Bennett Corp. · Nov 1997
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · Draeger Medical, Inc. · Mar 1996
MODEL 7200AE VENTILATOR
K922705 · Puritan Bennett Corp. · Sep 1994
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K922975 · Puritan Bennett Corp. · Sep 1994