# K053130: Onyx II Finger Pulse Oximeter, Model 9550

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jan 11, 2006 after 64 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: 2 generations back to K001085 (2000). 2 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051107: Onyx II Finger Pulse Oximeter, Model 9550, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K081285: Finger Pulse Oximeter, Model 9560 (2008), 40 descendants of its own
- K112843: Pulse Oximeter (2012), 27 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own
- K163382: Oxitone 1000 (2017), 17 descendants of its own

## Indications for use
The Nonin ® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 2.5 cm) thick. The index finger is the recommended site.

Source page: https://510kreport.com/device/K053130
Methodology: https://510kreport.com/methodology