Cleared Special

K093923 - CEROX MODEL 3210 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K093923.
Masimo O3 Regional Oximeter
K243324 · Masimo Corporation · Jul 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · Vioptix, Inc. · Jun 2025
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · Edwards Lifesciences · Oct 2024
ODI-Tech
K241393 · Odi Medical AS · Aug 2024
SnapshotNIR model KD205
K240601 · Kent Imaging, Inc. · Apr 2024
OxiplexTS200
K232385 · Iss Medical, Inc. · Mar 2024