# K041647: Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible)

- Pathway: 510(k) (Traditional)
- Applicant: Elekon Industries U.S.A., Inc.
- Decided: Sep 2, 2004 after 77 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: 4 generations back to K962603 (1997). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) 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
- K086378: Nellcor, BCL, and Datex pulse oximeter sensors. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K042704: Reusable Finger Clip SPO2 Sensors (2004), 1 descendant of its own
- K061191: Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use with Nellcor R-Cal SPO2 (2006), 0 descendants of its own

## Indications for use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >30 kg

Source page: https://510kreport.com/device/K041647
Methodology: https://510kreport.com/methodology