Cleared Traditional

K091564 - NBM-200MP PULSE OXIMETRY DEVICE

K091564 is an FDA 510(k) clearance for NBM-200MP PULSE OXIMETRY DEVICE, 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 295-day FDA review.

K091564 · Orsense, Ltd. · Anesthesiology device
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Mar 2010
Decision
295d
Days
Class 2
Risk

K091564 is an FDA 510(k) clearance for the NBM-200MP PULSE OXIMETRY DEVICE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Orsense, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on March 19, 2010 after a review of 295 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 - K091564

510(k) Number K091564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2009
Decision Date March 19, 2010
Days to Decision 295 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
155d slower than avg
Panel avg: 140d · This submission: 295d
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 K091564.
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D
K100617 · Masimo Corporation · May 2010
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
K093881 · GE Healthcare Finland Oy · Mar 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · Nonin Medical, Inc. · Mar 2010
MD300C1 FINGERTIP PULSE OXIMETER
K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010