# K121914: Masimo Set USPO2 Pulse Oximetry Cable

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Sep 7, 2012 after 67 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 1.

## Recalls of this device
- Sep 30, 2014 · Class II · Z-0213-2015: Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value w

## Indications for use
The Masimo SET® USPO₂ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor). The Masimo SET® USPO₂ Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K121914
Methodology: https://510kreport.com/methodology