# K061191: Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use with Nellcor R-Cal SPO2

- Pathway: 510(k) (Special)
- Applicant: Measurement Specialties, Inc.
- Decided: May 22, 2006 after 24 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: 6 generations back to K962603 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042704: Reusable Finger Clip SPO2 Sensors, Elekon Industries U.S.A., Inc. (2004) Summary page 2.
- K042675: Flexi-Stat SP02 Ear Sensor, Elekon Industries U.S.A., Inc. (2004) Summary page 2.
- K042705: Disposable Non-Adhesive SPO2 Sensors, Elekon Industries U.S.A., Inc. (2004) Summary page 2.
- K041522: Flexi-Stat Disposable Adhesive SPO2 Sensors, Elekon Industries U.S.A., Inc. (2004) Summary page 2.

## Indications for use
The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. The Ear Sensor for use with Nellcor& R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg. The Neonatal-Adult Sensor for use with NellcorS R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients. The Adult/Pediatric Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.

Source page: https://510kreport.com/device/K061191
Methodology: https://510kreport.com/methodology