Data / Medical devices / Switzerland / Sentec AG

Sentec AG: FDA-registered device maker in THERWIL Basel-Landschaft, Switzerland, 6 510(k) clearances

Name: Sentec AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sentec AG is registered with the FDA (registration 3004149774) in THERWIL Basel-Landschaft, Switzerland. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 7, 2025. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Sentec AG

FDA registration number: 3004149774
Address: Ringstrasse 39, THERWIL Basel-Landschaft, Switzerland, CH-4106
Owner or operator: SENTEC AG (9064082)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: December 16, 2008
Registered through: 2026
Brand names listed: 103149 Calibration Gas tCOM+, 103164 tCOM+ Patient Monitor, 103420 Sensor Adapter Cable (Regular) tCOM+, 103421 Sensor Adapter Cable (Long) tCOM+, 103422 Sensor Adapter Cable (Extra Long) tCOM+, 103520 Non-Adhesive Wrap, 103583 LuMon Contact Gel, 1ST120-100 LuMon Connector 2 and more

Devices it lists

Device	Product code	Class	Role	Source
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Ventilatory Electrical Impedance Tomograph	QEB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 7, 2025	K243765	LuMon(TM) System	QEB	Substantially Equivalent	Sentec AG	accessdata.fda.gov
May 17, 2024	K232516	Sentec Digital Monitoring System (SDMS) tCOM+	LKD	Substantially Equivalent	Sentec AG	accessdata.fda.gov
December 17, 2015	K151329	SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet	LKD	Substantially Equivalent	Sentec AG	accessdata.fda.gov
December 3, 2010	K101690	SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE	LKD	Substantially Equivalent	Sentec AG	accessdata.fda.gov
September 12, 2007	K071672	SENTEC DIGITAL MONITORING SYSTEM	DQA	Substantially Equivalent	Sentec AG	accessdata.fda.gov
August 9, 2004	K041548	SENTEC DIGITAL MONITOR MODEL #SDM	LKD	Substantially Equivalent	Sentec, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 25, 2023	92833	Class II	Ongoing	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	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.	accessdata.fda.gov
May 2, 2023	92355	Class II	Ongoing	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.	accessdata.fda.gov
August 22, 2022	90938	Class II	Terminated	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.	accessdata.fda.gov
December 10, 2020	87054	Class II	Terminated	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 o	Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.	accessdata.fda.gov
May 2, 2019	83115	Class II	Terminated	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 ped	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.	accessdata.fda.gov
September 15, 2016	75257	Class II	Terminated	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 an	accessdata.fda.gov
March 25, 2015	70878	Class II	Terminated	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 tran	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 aforementi	accessdata.fda.gov
November 5, 2012	63631	Class II	Terminated	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 continuou	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.	accessdata.fda.gov
July 9, 2012	62589	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated August 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.