# K071672: Sentec Digital Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sentec AG
- Decided: Sep 12, 2007 after 85 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915699 (1993). 12 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041548: Sentec Digital Monitor Model #SDM, Sentec, Inc. (2004) Summary page 1.
- K063434: Tosca 500 TCPCO2,  SPO2 and Pulse Rate Monitoring System, Radiometer Basel AG (2007) Summary page 1.
- K991644: Microgas 7650 Transcutaneous Monitor, Linde Medical Sensors AG (1999) Summary page 1.

## Most influential descendants
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), 3 descendants of its own
- 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
- 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), the V-Sign Sensor 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. The V-Sign Sensor, model VS-A/P, 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. In neonatal patients the use of the V-Sign Sensor is indicated for carbon dioxide tension monitoring only. SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign Sensor 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 the V-Sign Sensor 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 Ring, model MAR-A/P/N, is intended for use with the V-Sign Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign Sensor to conventional measurement sites for carbon dioxide tension monitoring. SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign Sensor to conventional measurement sites for carbon dioxide tension monitoring.

Source page: https://510kreport.com/device/K071672
Methodology: https://510kreport.com/methodology