# K100225: Pulse Oximeter Model P10

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Feb 9, 2011 after 379 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: 3 generations back to K000126 (2000). 10 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K963707: Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40), Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K071610: Mediaid Pulse Oximeter M30 and M34, Mediaid, Inc. (2007) Summary page 1.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 1.

## Most influential descendants
- K152659: V10 (2016), 2 descendants of its own
- K170497: V10 (2017), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO 2) and pulse rate in all areas of a hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist. Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.

Source page: https://510kreport.com/device/K100225
Methodology: https://510kreport.com/methodology