# K060675: Envitec Reusable Softip Y SPO2 Sensors

- Pathway: 510(k) (Special)
- Applicant: Envitec-Wismar GmbH
- Decided: Jul 17, 2006 after 125 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: 7 generations back to K941811 (1994). 31 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043463: Envitec Reusable Multi-Site Y SPO2 Sensors, Envitec-Wismar GmbH (2005) Summary page 1.

## Most influential descendants
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), 3 descendants of its own
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), 1 descendant of its own
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 0 descendants of its own
- K162014: Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) (2017), 0 descendants of its own

## Indications for use
EnviteC Reusable SoftY SP02 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02) and pulse rate for adult, pediatric, and infant patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K060675
Methodology: https://510kreport.com/methodology