# K124041: NBM-200MP

- Pathway: 510(k) (Traditional)
- Applicant: Orsense, Ltd.
- Decided: Oct 17, 2013 after 293 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: 13 generations back to K962603 (1997). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 62 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091564: NBM-200MP Pulse Oximetry Device, Orsense, Ltd. (2010) Summary page 2.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 2.
- K091057: Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories, Masimo Corporation (2009) Summary page 2.
- K082052: Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot Check, Masimo Corporation (2008) Summary page 2.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 4.

## Most influential descendants
- K142209: Pulse oximeter NBM-200 (2015), 0 descendants of its own

## Indications for use
The NBM-200MP is a portable Hemoglobin and oximetry monitor. It non-invasively monitors and displays Hemoglobin (Hb), estimated Hematocrit (Hct), functional saturation of arterial oxygen hemoglobin (SpO2), temporary occluded blood oxygen saturation (SoO2), pulse rate (PR) and plethysmogram waveform. For oximetry (SpOZISOO2). the NBM-200MP permits continuous patient monitoring with adjustable alarm limits, as well as visible and audible alarm Signals- SoO 2 is intended for use in low perfusion conditions and under any conditions that will cause poor signal quality. The NBM-200MP periodically displays Hemoglobin (Hb) and estimated Heniatocrit (Hot) values and it can also be used for spot measurements. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (i.e. I I to 17 gtdl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in clinical and non-c linical settings (e.g. hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers).

Source page: https://510kreport.com/device/K124041
Methodology: https://510kreport.com/methodology