# K042675: Flexi-Stat SP02 Ear Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Elekon Industries U.S.A., Inc.
- Decided: Dec 6, 2004 after 68 days
- Product code: DPZ (Oximeter, Ear)
- Device class: 2
- Regulation: 21 CFR 870.2710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944760 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944760: Dura-Y Oxygen Transducer, Ear Clip, Nellcor, Inc. (1994) 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
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg

Source page: https://510kreport.com/device/K042675
Methodology: https://510kreport.com/methodology