# K041548: Sentec Digital Monitor Model #SDM

- Pathway: 510(k) (Traditional)
- Applicant: Sentec, Inc.
- Decided: Aug 9, 2004 after 61 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: 3 generations back to K915699 (1993). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991644: Microgas 7650 Transcutaneous Monitor, Linde Medical Sensors AG (1999) Summary page 1.
- P810037: Kontron Cutaneous PCO2 Monitor, Kontron Cardiovascular. FDA lists this PMA only through its supplements; the earliest we hold is P810037/S001 (Sep 16, 1982). Summary page 1.
- K972468: NPB-195 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (1997) Summary page 1.
- (no number) Dura-Y Oxygen Transducer, Ear Clip: named in the summary without a submission number

## Most influential descendants
- K071672: Sentec Digital Monitoring System (2007), 4 descendants of its own
- 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
- 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.
- May 2, 2023 · Class II · Z-1980-2023: 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.
- 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 Monitor System (comprising the SenTec Digital Monitor, V-Sign Sensor and Accessories) is indicated for continuous non-invasive patient monitoring. The SenTec Digital Monitor System is indicated for use in hospitals, hospital-type facilities, intra-hospital transport environments, and, if under clinical supervision, home environments. The SenTec Digital Monitor 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 carbon dioxide tension, oxygen saturation and pulse rate monitoring are required for adult through pediatric patients. 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 indicated for patients weighing 10 kg or more, using exclusively the ear lobe as a monitoring site. The use of the SenTec Ear Clip is contraindicated for patients whose ear-lobes are very small (resulting in inadequate sensor application). Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K041548
Methodology: https://510kreport.com/methodology