# K093853: Single-Patient Use Disposable Sensor Series

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 4, 2010 after 170 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.
2 later devices descend from it; 2 cite it directly.
1 of 12 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
- K071128: Scanscope XT System, Aperio Technologies (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K103685: Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI, RST063CA (2011), 0 descendants of its own
- K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda  Compatible Disposable and Reusable SPO2 Sensors (2011), 0 descendants of its own

## Indications for use
Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult 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. Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 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. Nonin's Models 6000CI and 70001 Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 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. Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 pounds (<2 kilograms) or adults weighing greater than 66 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/K093853
Methodology: https://510kreport.com/methodology