# Sentec AG

- Location (FDA's records): Egale, WI
- FDA decisions: 7 (1986–2025): 7 510(k) clearances
- Names in FDA's records: Sentec AG (5); Sentec, Inc. (1); Sentec Corp. (1)
- Product codes: LKD (4), QEB (1), IZW (1), DQA (1)
- Predicates its devices cite: 19 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 14 (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)
- Linde Medical Sensors AG: 2 (https://510kreport.com/company/linde-medical-sensors)
- Radiometer Basel AG: 2 (https://510kreport.com/company/radiometer-basel)
- Timpel S.A.: 1 (https://510kreport.com/company/timpel)
- Radiometer Medical Aps: 1 (https://510kreport.com/company/radiometer-medical)
- Envitec-Wismar GmbH: 1 (https://510kreport.com/company/envitec-wismar)
- Cardiopulmonary Corp.: 1 (https://510kreport.com/company/cardiopulmonary)

## Firms that cite its devices most
- Bluepoint Medical GmbH & Co. KG: 1 (https://510kreport.com/company/bluepoint-medical)

## Its most-cited devices
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), cited by 3
- K041548: Sentec Digital Monitor Model #SDM (2004), cited by 2
- K071672: Sentec Digital Monitoring System (2007), cited by 2
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), cited by 1

## Recent decisions
- K243765: LuMon (TM) System (Aug 7, 2025)
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (Dec 17, 2015)
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (Dec 3, 2010)
- K071672: Sentec Digital Monitoring System (Sep 12, 2007)
- K041548: Sentec Digital Monitor Model #SDM (Aug 9, 2004)
- K862340: Sentec Laser Guide Line, Model SGL-05 (Jul 11, 1986)

Source page: https://510kreport.com/company/sentec