# K042704: Reusable Finger Clip SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Elekon Industries U.S.A., Inc.
- Decided: Nov 26, 2004 after 57 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: 5 generations back to K962603 (1997). 9 ancestors in all.
1 later device descends 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)
- K041647: Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible), Elekon Industries U.S.A., Inc. (2004) Summary page 1.

## Most influential descendants
- 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 SpO 2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 kg.

Source page: https://510kreport.com/device/K042704
Methodology: https://510kreport.com/methodology