# K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable

- Pathway: 510(k) (Traditional)
- Applicant: Sentec AG
- Decided: Dec 3, 2010 after 170 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941811 (1994). 47 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071672: Sentec Digital Monitoring System, Sentec AG (2007) Summary page 2.
- K063434: Tosca 500 TCPCO2,  SPO2 and Pulse Rate Monitoring System, Radiometer Basel AG (2007) Summary page 1.
- K060675: Envitec Reusable Softip Y SPO2 Sensors, Envitec-Wismar GmbH (2006) Summary page 4.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K961450: Score Software, Nellcor Puritan Bennett, Inc. (1996) Summary page 2.
- K091461: Bernoulli Management System, Oxinet Iii and Lifegard Vue, Cardiopulmonary Corp. (2009) Summary page 2.
- (no number) TCM4/40 Monitoring System: named in the summary without a submission number

## Most influential descendants
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), 1 descendant of its own
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 0 descendants of its own
- K162014: Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) (2017), 0 descendants of its own

## Recalls of this device
- Jul 25, 2023 · Class II · Z-2592-2023: 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.
- Dec 10, 2020 · Class II · Z-1134-2021: Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
- May 2, 2019 · Class II · Z-2155-2019: 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.
- May 2, 2019 · Class II · Z-2153-2019: 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.
- May 2, 2019 · Class II · Z-2154-2019: 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.
- May 2, 2019 · Class II · Z-2152-2019: 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.
- May 2, 2019 · Class II · Z-2156-2019: 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.
- Sep 15, 2016 · Class II · Z-0088-2017: 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 scre
- Mar 25, 2015 · Class II · Z-1501-2015: 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 the
- Nov 5, 2012 · Class II · Z-0433-2013: 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 d
- Nov 5, 2012 · Class II · Z-0434-2013: 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 d
- Jul 9, 2012 · Class II · Z-2199-2012: SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

## Indications for use
The SenTec Digital Monitoring System - consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospitals, hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only. V-Sign Sensor, model VS-N/P, and V-Sign Sensor 2, model VS-N/P/N, are 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. In neonatal patients the use of V-Sign Sensor and of V-Sign Sensor 2 is indicated for carbon dioxide tension monitoring only. SenTec's Ear Clip, model EC-MI, is intended for use with V-Sign Sensor or V-Sign Sensor 2 when continuous, non-invasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach V-Sign Sensor or V-Sign Sensor 2 to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application. SenTec's Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach V-Sign Sensor or V-Sign Sensor 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, non-invasive carbon dioxide tension monitoring is required for adult, pediatric, and neonatal patients. They are intended to attach the V-Sign Sensor 2 to the forehead or the cheek when continuous, non-invasive carbon dioxide tension, oxygen saturation, and pulse rate monitoring is required for adult and pediatric patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are for single use. SenTec's multi-compatible and reusable SpO2 Soft Sensors models RSS-L, RSS-M and RSS-S, are indicated for use with the monitoring devices indicated in the respective sensor directions for use when continuous non-invasive monitoring of oxygen saturation, and pulse rate are required for patients weighing more than 20 kg. V-STATS is an optional PC-based software which is indicated for use with the SenTec Digital Monitor (SDM) when remote monitoring and/or trend reporting and statistical analysis of the data measured by the SDM is required. V-STATS is not intended to provide diagnosis, it is intended to supplement and not to replace any part of the SDM monitoring procedures.

Source page: https://510kreport.com/device/K101690
Methodology: https://510kreport.com/methodology