# K030930: Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: May 23, 2003 after 59 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: 5 generations back to K962603 (1997). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 4.

## Most influential descendants
- K050583: Model 250 Series Maternal/Fetal Monitor (2005), 1 descendant of its own
- K072976: Model 250CX Series Maternal/Fetal Monitor (2007), 0 descendants of its own
- K041964: Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and Adhesive SPO2 Sensors (2004), 0 descendants of its own
- K041644: Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible) (2004), 0 descendants of its own

## Indications for use
The Nellcor OxiMax Softcare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg. The Nellcor OxiMax Softcare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg. The Nellcor OxiMax Softcare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg. The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg.

Source page: https://510kreport.com/device/K030930
Methodology: https://510kreport.com/methodology