# K091564: NBM-200MP Pulse Oximetry Device

- Pathway: 510(k) (Traditional)
- Applicant: Orsense, Ltd.
- Decided: Mar 19, 2010 after 295 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000126 (2000). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053269: Masimo Set Rad-8 Pulse Oximeter, Masimo Corporation (2005) Summary page 2.
- K910077: Crit-Scan, Noninvasive Medical Technology Corp. (1992) Summary page 2.
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics, Bmeye B.V. (2007) Summary page 2.

## Most influential descendants
- K124041: NBM-200MP (2013), 1 descendant of its own
- K142209: Pulse oximeter NBM-200 (2015), 0 descendants of its own

## Indications for use
The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform. Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions. It may be used on adult patients in the hospital or clinical environments. The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals. The NBM-200MP is NOT intended for home use.

Source page: https://510kreport.com/device/K091564
Methodology: https://510kreport.com/methodology