# K041644: Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible)

- Pathway: 510(k) (Traditional)
- Applicant: Elekon Industries U.S.A., Inc.
- Decided: Jul 29, 2004 after 42 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 K962603 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030930: Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N, Nellcor Puritan Bennett, Inc. (2003) Summary page 1.
- K962156: 3304 Pulse Oximeter, Bci Intl., Inc. (1996) Summary page 1.
- K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters, Datex-Ohmeda, Inc. (1998) Summary page 1.
- K992215: Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped, Envitec-Wismar GmbH (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K86378: Nellcor, BCI, and Datex pulse oximeter sensors. Number could not be read Summary page 1.

## Indications for use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.

Source page: https://510kreport.com/device/K041644
Methodology: https://510kreport.com/methodology