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)
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.

View all Or-Nim Medical , Ltd. devices

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 60
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K093923.
INPECTRA STO2 SPOT CHECK
K103613 · Hutchinson Technology, Inc. · Mar 2011
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
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · Nonin Medical, Inc. · Jun 2009
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · Cas Medical Systems, Inc. · Sep 2006