# Elekon Industries U.S.A., Inc.

- Location (FDA's records): Plano, TX
- FDA decisions: 6 (2004–2004): 6 510(k) clearances
- Product codes: DQA (5), DPZ (1)
- Predicates its devices cite: 15 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 3 (https://510kreport.com/company/nellcor-puritan-bennett)
- Bci Intl., Inc.: 3 (https://510kreport.com/company/bci-intl)
- Datex-Ohmeda, Inc.: 3 (https://510kreport.com/company/datex-ohmeda)
- Envitec-Wismar GmbH: 3 (https://510kreport.com/company/envitec-wismar)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)

## Firms that cite its devices most
- Measurement Specialties, Inc.: 4 (https://510kreport.com/company/measurement-specialties)

## Its most-cited devices
- K041522: Flexi-Stat Disposable Adhesive SPO2 Sensors (2004), cited by 2
- K042675: Flexi-Stat SP02 Ear Sensor (2004), cited by 1
- K042704: Reusable Finger Clip SPO2 Sensors (2004), cited by 1
- K042705: Disposable Non-Adhesive SPO2 Sensors (2004), cited by 1
- K041647: Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible) (2004), cited by 1

## Recent decisions
- K042705: Disposable Non-Adhesive SPO2 Sensors (Dec 29, 2004)
- K042675: Flexi-Stat SP02 Ear Sensor (Dec 6, 2004)
- K042704: Reusable Finger Clip SPO2 Sensors (Nov 26, 2004)
- K041522: Flexi-Stat Disposable Adhesive SPO2 Sensors (Sep 14, 2004)
- K041647: Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible) (Sep 2, 2004)
- K041644: Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible) (Jul 29, 2004)

Source page: https://510kreport.com/company/elekon-industries-usa