# K143219: Niro-200NX

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Jul 31, 2015 after 263 days
- Product code: MUD (Oximeter, Tissue Saturation)
- 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 K001842 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 4.
- K011320: Etg-100 Optical Encephalography System, Hitachi Medical Systems America, Inc. (2001) Summary page 4.
- K042501: Etg-4000 Optical Topography System, Hitachi Medical Corp. (2004) Summary page 4.

## Most influential descendants
- K162117: Niro-200NX DP (2016), 0 descendants of its own

## Indications for use
The NIR0-200NX is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NIR0-200NX should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K143219
Methodology: https://510kreport.com/methodology