510(k) · Cleared
Recalled · Class II · 2023Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable
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 3, 2010 as substantially equivalent to K071672 (Sentec AG, 2007) and 5 other predicates after a 170-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it. It has been recalled 12 times.
- Decided
- Dec 3, 2010
- Review
- 170 days
- Class
- Class II
- Product code
- LKD
- Recalls
- 12
- Predicates
- 6
Its longest line of descent runs back 8 generations to K941811 (1994). 47 ancestors in all, the oldest K882609 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 3 generations backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
- 2 generations backK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- 1 generation backK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- This deviceK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010
- Descendant · cites it directly · 1 of its ownK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
- Descendant · cites it directly · 0 of its ownK162014 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small…Bluepoint Medical GmbH & Co. KG · 2017
Most influential descendants
Showing 3 of 3 · See all- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · cites it directly1descendant
- K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · cites it directly0descendants
- K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −3 | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | Philips Medical Systems, Inc. | 2004 | — |
| −2 | K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | Envitec-Wismar GmbH | 2005 | — |
| −1 | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | — |
| 0 (this device) | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | — |
| +1 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | 9 |
| +1 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024 | — |
| +1 | K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor… | Bluepoint Medical GmbH & Co. KG | 2017 | — |
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 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K071672 | Sentec Digital Monitoring SystemSummary page 2…meters] Reason For Submission: Additional or Expanded Indications Description of the device [807.92(a)(4)]: The SenTec Digital Monitoring System (SDMS) as listed under K071672 is a device consisting of a stand-, alone monitor [SenTec Digital Monitor (5DM)], a digital sensor [V-Sign T " Sensor (model VS-N… | 2007 |
| * | K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemSummary page 1…These two devices are predicates for the expanded TOSCA 500 tcPCO2, SpO 2 sensor temperature and site time management as K063434 adPMoioigw m Radiometer Base] AG well as for the new parameter 'Heating Power' being… | 2007 |
| * | K060675 | Envitec Reusable Softip Y SPO2 SensorsSummary page 4…C series SpO2 Adapter Cable is a reusable, conventional oximetry sensor which is applied to a patients digit. It utilizes an existing EnviteC sensor design cleared under K060675. All relevant patient monitoring features of the SenTec Digital Monitoring System are equivalent to the SOMS configuration liste… | 2006 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…S__________ SenTec's new Sp0 2 Soft Sensor being connected to - -Nellcor K1991823 IN-395 Pulse Oximeter Bennett,Puritan Inc. the 5DM with… | 1999 |
| * | K961450 | Score SoftwareSummary page 2…is (SenTecds optional PC software). Score Softwaredata K961450 ScoreSoftware) Bennett, Inc. predicate for V-STATSTh's claim to download (PC… | 1996 |
| * | K091461 | Bernoulli Management System, Oxinet Iii and Lifegard VueSummary page 2…and reporting. Oxinet III software is BemoulliTm Management ~riploay predicate for V-STATSTh's claim for remote K091461 SstemiOpietmo!aan monitoring. [Note: Neilcors OxiNet III is a privat… | 2009 |
| * | — | TCM4/40 Monitoring System Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. |
| 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… |
| Mar 25, 2015 | Class II | Z-1501-2015 | Under Investigation by firm | 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 their end-of-life earlier than normally… |
| Nov 5, 2012 | Class II | Z-0433-2013 | Component design/selection | 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 deteriorated. |
| Nov 5, 2012 | Class II | Z-0434-2013 | Component design/selection | 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 deteriorated. |
| Jul 9, 2012 | Class II | Z-2199-2012 | Device Design | SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing. |
The 5 latest of 12 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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 46 ancestors have a recall of any class.
- Of its descendants, K151329 (Sentec AG, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071672.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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, 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…
Read the full statement (389 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101690
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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