# K090438: Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Jul 24, 2009 after 154 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: 9 generations back to K941811 (1994). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T, Philips Medical Systems (2006) Summary page 1.
- K030973: Picosat II SPO2 Pulse Oximetry Module, Philips Medical Systems (2003) Summary page 1.
- K053419: Konica Minolta Pulsox-300, 300I, Konica Minolta Sensing, Inc. (2006) Summary page 1.

## Indications for use
EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.

Source page: https://510kreport.com/device/K090438
Methodology: https://510kreport.com/methodology