Cleared Special

K142209 - Pulse oximeter NBM-200

K142209 is an FDA 510(k) clearance for Pulse oximeter NBM-200, manufactured by Orsense, Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 158-day FDA review.

K142209 · Orsense, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
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Jan 2015
Decision
158d
Days
Class 2
Risk

K142209 is an FDA 510(k) clearance for the Pulse oximeter NBM-200. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Orsense, Ltd. (Petah-Tikva, IL). The FDA issued a Cleared decision on January 16, 2015 after a review of 158 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orsense, Ltd. devices

FDA 510(k) Submission Details - K142209

510(k) Number K142209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date January 16, 2015
Days to Decision 158 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

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 K142209.
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K141542 · Covidien, LLC · Oct 2014
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K141128 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2014