# K162117: Niro-200NX DP

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Oct 25, 2016 after 88 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: 5 generations back to K001842 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143219: Niro-200NX, Hamamatsu Photonics K.K. (2015) Summary page 4.

## Indications for use
The NIRO-200NX DP 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 NIRO-200NX DP should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K162117
Methodology: https://510kreport.com/methodology