Sentec AG
FDA Regulatory Profile
Sentec AG appears in FDA public data with 14 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2592-2023, Class II) was initiated on July 25, 2023. Its most recent 510(k) clearance was granted on August 7, 2025.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2592-2023 | Class II | Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, | July 25, 2023 |
| Z-1980-2023 | Class II | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). | May 2, 2023 |
| Z-0148-2023 | Class II | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuo | August 22, 2022 |
| Z-1134-2021 | Class II | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuou | December 10, 2020 |
| Z-2155-2019 | Class II | SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, | May 2, 2019 |
| Z-2153-2019 | Class II | SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indic | May 2, 2019 |
| Z-2154-2019 | Class II | SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indic | May 2, 2019 |
| Z-2152-2019 | Class II | SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invas | May 2, 2019 |
| Z-2156-2019 | Class II | SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive mon | May 2, 2019 |
| Z-0088-2017 | Class II | SDMS (SenTec Digital Monitoring System) | September 15, 2016 |
| Z-1501-2015 | Class II | Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Ther | March 25, 2015 |
| Z-0433-2013 | Class II | SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated f | November 5, 2012 |
| Z-0434-2013 | Class II | SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert | November 5, 2012 |
| Z-2199-2012 | Class II | SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and | July 9, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243765 | LuMon(TM) System | August 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 in | December 17, 2015 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | December 3, 2010 |
| K071672 | SENTEC DIGITAL MONITORING SYSTEM | September 12, 2007 |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | August 9, 2004 |
| K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 | July 11, 1986 |