# K112843: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Apr 19, 2012 after 203 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: 3 generations back to K001085 (2000). 3 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053130: Onyx II Finger Pulse Oximeter, Model 9550, Nonin Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K163382: Oxitone 1000 (2017), 17 descendants of its own
- K181006: BB-613 Watch Oximeter (2018), 15 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K193350: Leadtek Fingertip Pulse Oximeter (2020), 4 descendants of its own

## Indications for use
The Nonin® Onyx Vantage 9590 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%Sp02) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on digits, including the thumb and toes, that are between 0.3 - 1.0 inch (0.8 — 2.5 cm) thick. The device’s intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.

Source page: https://510kreport.com/device/K112843
Methodology: https://510kreport.com/methodology