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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Goodwin/Procter Llp
Mark A Heller

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 687
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