# K992215: Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped

- Pathway: 510(k) (Traditional)
- Applicant: Envitec-Wismar GmbH
- Decided: Mar 29, 2000 after 272 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
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series (2009), 7 descendants of its own
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 descendants of its own
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K041522: Flexi-Stat Disposable Adhesive SPO2 Sensors (2004), 2 descendants of its own
- K041647: Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible) (2004), 2 descendants of its own

## Indications for use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Source page: https://510kreport.com/device/K992215
Methodology: https://510kreport.com/methodology