# K991884: Siemens FIO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 3, 1999 after 154 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K833326 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961644: Miniox 3000 Oxygen Monitor, Minesafety Appliances Co. (1996) Summary page 1.

## Indications for use
Siemens FiO2 sensor is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the oxygen level of ambient air in non-pressurized environments such as that found in infant incubators and oxygen hoods. The Siemens FiO2 sensor is not intended for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K991884
Methodology: https://510kreport.com/methodology