Cleared Traditional

K960861 - OMICRON MONITOR, DELTA MONITOR

K960861 is an FDA 510(k) clearance for OMICRON MONITOR, manufactured by Core-M, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K960861

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
Combination Product No
PCCP Authorized No
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.

CBK Device Classification - Class 2, Special Controls

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 366
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K960861.
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K960168 · Siemens Elema AB · Oct 1996
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
DRAGER MICRO VENT
K953238 · Drager, Inc. · Sep 1996
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · Allied Healthcare Products, Inc. · Aug 1996
MODEL LP-1000 VOLUME VENTILATOR
K952880 · Aequitron Medical, Inc. · Jun 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996