# K102270: Envitec Reusable SPO2 Sensors Type Nihon-Kohden

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Feb 22, 2011 after 196 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: 2 generations back to K001693 (2000). 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)
- K011918: Nihon  Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series, Nihon Kohden America, Inc. (2001) Summary page 1.

## Indications for use
EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02) 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/K102270
Methodology: https://510kreport.com/methodology