510(k) · Cleared
Recalled · Class II · 2023SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentec AG · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Dec 17, 2015 as substantially equivalent to K101690 (Sentec AG, 2010) and 1 other predicate after a 213-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Dec 17, 2015
- Review
- 213 days
- Class
- Class II
- Product code
- LKD
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 9 generations to K941811 (1994). 50 ancestors in all, the oldest K882609 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- 2 generations backK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- 1 generation backK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- This deviceK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015
- Descendant · cites it directly · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 4 generations backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
- 3 generations backK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- 2 generations backK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- 1 generation backK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- This deviceK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015
Most influential descendants
Showing 1 of 1 · See all- K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −4 | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | Philips Medical Systems, Inc. | 2004 | — |
| −3 | K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | Envitec-Wismar GmbH | 2005 | — |
| −2 | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | — |
| −1 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| 0 (this device) | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | — |
| +1 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKD device
- #1 K232516 Sentec Digital Monitoring System (SDMS) tCOM+score 10.1 · 10 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSummary page 5…monitoring for monitoring of PCO2, SpO2, and PR at SenTec Digital Monitoring the ear lobe, forehead and cheek in adult and K101690 SenTec AG System pediatric patients and… | 2010 |
| * | K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring SystemSummary page 5…conventional PCO2 measurement sites. This device is the predicate for PO2 monitoring on K093154 TCM CombiM Radiometer conventional PO2 monitoring sites in adult and… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2023 | Class II | Z-2592-2023 | Process control | 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 | Under Investigation by firm | Weak skin adhesion. |
| Dec 10, 2020 | Class II | Z-1134-2021 | Device Design | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Component change control | 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… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 49 ancestors have a recall of any class.
- Of its descendants, K232516 (Sentec AG, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101690.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LKD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LKD
Too few LKD 510(k)s in any year since 2007 to give a median.
Recalls per year · LKD
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKD
3in 2025
MAUDE reports naming product code LKD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 1 | 21 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (538 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151329
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026