Company ยท US
SenTec AG
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2025 | K243765 | LuMon(TM) System Sentec AG, CH | QEB |
| May 17, 2024 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ Sentec AG, CH | LKD |
| Dec 17, 2015 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, CH | LKD |
| Dec 3, 2010 | K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG | LKD |
| Sep 12, 2007 | K071672 | SENTEC DIGITAL MONITORING SYSTEM Sentec AG | DQA |
| Aug 9, 2004 | K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc. | LKD |
| Jul 11, 1986 | K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 Sentec Corp. | IZW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2023 | SenTec AG Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package cont Open, Classified |
LKD | K041548 K101690 +1 |
| Jun 20, 2023 | SenTec AG V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Open, Classified |
LKD | K041548 |
| Oct 28, 2022 | SenTec AG sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring. Terminated |
LKD | K151329 |
| Dec 10, 2020 | SenTec AG SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure Terminated |
LKD | K041548 K101690 +1 |
| May 2, 2019 | SenTec AG SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in Terminated |
LKD | K041548 K101690 +1 |
| May 2, 2019 | SenTec AG SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation an Terminated |
LKD | K041548 K101690 +1 |
| May 2, 2019 | SenTec AG SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as Terminated |
LKD | K041548 K101690 +1 |
| May 2, 2019 | SenTec AG SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as Terminated |
LKD | K041548 K101690 +1 |
| May 2, 2019 | SenTec AG SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse r Terminated |
LKD | K041548 K101690 +1 |
| Oct 17, 2016 | SenTec AG SDMS (SenTec Digital Monitoring System) Terminated |
LKD | K041548 K071672 +2 |
| Apr 22, 2015 | SenTec AG Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasi Terminated |
LKD | K101690 |
| Nov 22, 2012 | Sentec AG SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only.
The V-sign Sensor is indicated for use Terminated |
LKD | K101690 |
| Nov 22, 2012 | Sentec AG SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only.
The V-sign Sensor is indicated for use with the SenTec Digital Terminated |
LKD | K101690 |
| Aug 13, 2012 | Sentec AG SenTec, V-Sign"2 Sensors
The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). Terminated |
LKD | K101690 |