# K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet

- Pathway: 510(k) (Traditional)
- Applicant: Sentec AG
- Decided: Dec 17, 2015 after 213 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K941811 (1994). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable, Sentec AG (2010) Summary page 5.
- K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System, Radiometer Medical Aps (2010) Summary page 5.

## Most influential descendants
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 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.
- Aug 22, 2022 · Class II · Z-0148-2023: Weak skin adhesion.
- 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

## Indications for use
The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), Sensors and Accessories – is indicated for continuous, noninvasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in clinical and non-clinical settings such as hospitals, hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and – if under clinical supervision– home environments. The SenTec Digital Monitoring System is for prescription use only. The V-Sign Sensor 2, model VS-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive 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 2 is indicated for carbon dioxide tension monitoring only. The OxiVenT Sensor, model OV-A/P/N, is indicated for use with the SenTec Digital Monitor when continuous, noninvasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate are required for adult and pediatric patients. In neonatal patients the use of OxiVenT Sensor is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. SenTec’s Ear Clip, model EC-MI, is intended for use with the V-Sign Sensor 2 when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring and with the OxiVenT Sensor when continuous, noninvasive carbon dioxide and oxygen tension monitoring as well as oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign Sensor 2 or OxiVenT Sensor to the earlobe of the patient. The use of the Ear Clip is contraindicated for patients whose earlobes 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 2 to conventional measurement sites for carbon dioxide tension monitoring when continuous, noninvasive carbon dioxide tension monitoring is required for adult, pediatric, and neonatal patients. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the OxiVenT Sensor to conventional measurement sites for carbon dioxide and/or oxygen tension monitoring when continuous, noninvasive carbon dioxide and/or oxygen tension monitoring is required for adult, pediatric, and neonatal patients. If oxygen saturation and pulse rate monitoring are (additionally) required in adult and pediatric patients the Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are intended to attach the V-Sign Sensor 2 or the OxiVenT Sensor to the forehead, cheek, upper arm as well as on the back above the shoulder blade. The Multi-Site Attachment Rings, model MAR-SF and model MAR-MI, are for single use. SenTec’s Staysite Adhesive pad for MAR, model SA-MAR, is an optional, single-use adhesive pad which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF, if more secure attachment is required. The Staysite Adhesive pad for MAR, model SA-MAR, is for single use. 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 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/K151329
Methodology: https://510kreport.com/methodology