# K093306: Single-Patient Use Disposable Sensor

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Mar 4, 2010 after 133 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: 4 generations back to K950387 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063752: Lifesense, Model LS1-9R, Nonin Medical, Inc. (2007) Summary page 1.
- K023044: Model 9600, Avant Pulse Oximeter, Nonin Medical, Inc. (2003) Summary page 1.
- K050056: Model 2500A Palmsat Pulse Oximeter, Nonin Medical, Inc. (2005) Summary page 1.
- K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500, Nonin Medical, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K071280: Synchron CX Delta Clinical Systems, Creatinine Test Systems, Beckman Coulter, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Source page: https://510kreport.com/device/K093306
Methodology: https://510kreport.com/methodology