# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Oct 22, 2024 after 124 days
- Product code: NLF (Oximeter, Reprocessed)
- 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: 22 generations back to K962603 (1997). 155 ancestors in all.
No later device cites it as a predicate yet.
2 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Stryker Sustainability Solutions (2022) Summary page 6.
- K180046: Masimo Rad-97 and Accessories, Masimo Corporation (2018) Summary page 6.

## Indications for use
Reprocessed RD SET Pulse Oximeter Sensors are indicated for use in continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and infant patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. Reprocessed RD SET Pulse Oximeter Sensors are not intended to be used as the sole basis for making diagnosis or treatment decisions; they are intended to be used in conjunction with additional methods of assessing clinical signs and symptoms

Source page: https://510kreport.com/device/K241758
Methodology: https://510kreport.com/methodology