Cleared Traditional

K100875 - CEROX, MODEL 321OF

K100875 is an FDA 510(k) clearance for CEROX, manufactured by Or-Nim Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K100875 · Or-Nim Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
301d
Days
Class 2
Risk

K100875 is an FDA 510(k) clearance for the CEROX, MODEL 321OF. 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 25, 2011 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Or-Nim Medical , Ltd. devices

FDA 510(k) Submission Details - K100875

510(k) Number K100875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date January 25, 2011
Days to Decision 301 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K100875.
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · Nonin Medical, Inc. · May 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · Cas Medical Systems, Inc. · Jan 2012
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