# K090662: Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Aug 10, 2009 after 151 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K941811 (1994). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.

## Most influential descendants
- K113596: Masimo Set Reusable Oximetry Sensors (2012), 0 descendants of its own

## Recalls of this device
- Apr 4, 2016 · Class II · Z-2643-2017: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.

## Indications for use
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an SPO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K090662
Methodology: https://510kreport.com/methodology