# K051107: Onyx II Finger Pulse Oximeter, Model 9550

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 1, 2005 after 30 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: 1 generation back to K001085 (2000). 1 ancestor in all.
154 later devices descend from it; 4 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500, Nonin Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K070371: Fingertip Pulse Oximeter MD300C (2007), 79 descendants of its own
- K053130: Onyx II Finger Pulse Oximeter, Model 9550 (2006), 59 descendants of its own
- 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

## 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. 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/K051107
Methodology: https://510kreport.com/methodology