Sentec AG
THERWIL Basel-Landschaft, CH
SENTEC AG appears in FDA device records in THERWIL Basel-Landschaft, CH. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Sentec AG between 1986 and 2025. The busiest year on record is 1986, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2015 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243765 | LuMon(TM) System | QEB | Substantially Equivalent | |
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | LKD | Substantially Equivalent | |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | LKD | Substantially Equivalent | |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | LKD | Substantially Equivalent | |
| K071672 | SENTEC DIGITAL MONITORING SYSTEM | DQA | Substantially Equivalent | |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | LKD | Substantially Equivalent | |
| K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 | IZW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004149774 | 3004149774 | SENTEC AG | RINGSTRASSE 39, THERWIL Basel-Landschaft CH-4106 CH | 2026 | |
| 3012409105 | 3012409105 | SENTEC, INC. | 40 Albion Road, Lincoln, RI 02865 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2592-2023 | 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 contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS). | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance. | Class II | Open, Classified | |
| Z-1980-2023 | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode. | Class II | Open, Classified | |
| Z-0148-2023 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring. | Weak skin adhesion. | Class II | Terminated | |
| Z-1134-2021 | 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 (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor). | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. | Class II | Open, Classified | |
| Z-2156-2019 | 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 adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.] | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | Class II | Terminated | |
| Z-2155-2019 | 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 and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | Class II | Terminated | |
| Z-2154-2019 | 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 oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | Class II | Terminated | |
| Z-2153-2019 | 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 oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | Class II | Terminated | |
| Z-2152-2019 | 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 rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | Class II | Terminated | |
| Z-0088-2017 | SDMS (SenTec Digital Monitoring System) | Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator). | Class II | Terminated | |
| Z-1501-2015 | 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-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR). | SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens | Class II | Terminated | |
| Z-0434-2013 | 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 with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | Class II | Terminated | |
| Z-0433-2013 | 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 Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | Class II | Terminated | |
| Z-2199-2012 | 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). | SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Sentec AG edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain