# K043463: Envitec Reusable Multi-Site Y SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Feb 11, 2005 after 58 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: 6 generations back to K941811 (1994). 30 ancestors in all.
5 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)
- K944760: Dura-Y Oxygen Transducer, Ear Clip, Nellcor, Inc. (1994) Summary page 1.
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996) Summary page 1.
- K893877: Biochem 3100 Oximeter, Biochem International, Inc. (1989) Summary page 1.
- K910770: 504US Pulse Oximeter, Criticare Systems, Inc. (1991) Summary page 1.
- K010463: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires, Datex-Ohmeda, Inc. (2001) Summary page 1.
- K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T, Philips Medical Systems, Inc. (2004) Summary page 1.
- K890033: Model 8700 Pulse Oximeter, Nonin Medical, Inc. (1989) Summary page 1.
- K993979: MARSPO2, Model 2001, Novametrix Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K060675: Envitec Reusable Softip Y SPO2 Sensors (2006), 4 descendants of its own
- 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 Multi-site Y Sp0 2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. Not recommended for use on the ear.

Source page: https://510kreport.com/device/K043463
Methodology: https://510kreport.com/methodology