Cleared Traditional

K124041 - NBM-200MP

K124041 is an FDA 510(k) clearance for NBM-200MP, manufactured by Orsense, Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K124041 · Orsense, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
293d
Days
Class 2
Risk

K124041 is an FDA 510(k) clearance for the NBM-200MP. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Orsense, Ltd. (Washington, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 293 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Orsense, Ltd. devices

FDA 510(k) Submission Details - K124041

510(k) Number K124041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2012
Decision Date October 17, 2013
Days to Decision 293 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 140d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K124041.
PULSE OXIMETER
K140785 · Nonin Medical, Inc. · Jul 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · Nonin Medical, Inc. · Feb 2014
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
K130320 · Covidien · Feb 2014
FINGERTIP PULSE OXIMETER
K131047 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
FINGERTIP PULSE OXIMETER
K130947 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · GE Healthcare Finland Oy · Sep 2013