# K070193: Envitec Oxipen Pulse Oximeter and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: May 2, 2007 after 100 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 K915699 (1993). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963707: Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40), Nellcor Puritan Bennett, Inc. (1996) Summary page 1.

## Most influential descendants
- K113165: Mini-Medic (2012), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own

## Indications for use
The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories). The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K070193
Methodology: https://510kreport.com/methodology