Cleared Special

K093923 - CEROX MODEL 3210

K093923 is an FDA 510(k) clearance for CEROX MODEL 3210, manufactured by Or-Nim Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Special 510(k) pathway after a 28-day FDA review.

K093923 · Or-Nim Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
28d
Days
Class 2
Risk

K093923 is an FDA 510(k) clearance for the CEROX MODEL 3210. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Or-Nim Medical , Ltd. (Lod, IL). The FDA issued a Cleared decision on January 19, 2010 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093923

510(k) Number K093923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date January 19, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - MUD Oximeter, Tissue Saturation

All 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K093923.
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
K094030 · Cas Medical Systems, Inc. · Dec 2010
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc. · Dec 2010
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
K100915 · Hutchinson Technology, Inc. · Apr 2010
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
K091224 · Somanetics Corp. · Jul 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009
K093923 · CEROX MODEL 3210
Download PDF FDA Summary Or-Nim Medical , Ltd.