# K211140: Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Mar 8, 2022 after 326 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: 17 generations back to K941811 (1994). 68 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081238: Reprocessed Masimo Pulse Oximeter Sensors, Ascent Healthcare Solutions (2008) Summary page 5.
- K060143: LNCS and SPO2.Com Sensors, Masimo Corporation (2006) Summary page 5.

## Most influential descendants
- K222019: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (2022), 1 descendant of its own
- K241758: Reprocessed RD SET Adt Pulse Oximeter Sensor  (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (2024), 0 descendants of its own

## Indications for use
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

Source page: https://510kreport.com/device/K211140
Methodology: https://510kreport.com/methodology