510(k) · Cleared
ClearedSentec Digital Monitoring System (SDMS) tCOM+
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 May 17, 2024 as substantially equivalent to K041548 (Sentec, Inc., 2004) and 3 other predicates after a 273-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- May 17, 2024
- Review
- 273 days
- Class
- Class II
- Product code
- LKD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K941811 (1994). 51 ancestors in all, the oldest K882609 (1989). No later device cites it as a predicate yet.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- 2 generations backK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- 1 generation backK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- This deviceK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 5 generations backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
- 4 generations backK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- 3 generations backK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- 2 generations backK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- 1 generation backK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- This deviceK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −5 | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | Philips Medical Systems, Inc. | 2004 | — |
| −4 | K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | Envitec-Wismar GmbH | 2005 | — |
| −3 | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | — |
| −2 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| −1 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | 9 |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K041548 | Sentec Digital Monitor Model #SDMSummary page 6…cutaneous, for uses other than for infant not under gas anesthesia DQA – Oximeter DPZ- Oximeter, Ear Predicate 510(k)s: Sentec Digital Monitoring System (SDMS) with SDM K041548, K071672, K101690, K151329. Reason for Submission: Introduction of the new patient monitor tCOM+ and its accessories for the pre… | 2004 |
| * | K071672 | Sentec Digital Monitoring SystemSummary page 6…, for uses other than for infant not under gas anesthesia DQA – Oximeter DPZ- Oximeter, Ear Predicate 510(k)s: Sentec Digital Monitoring System (SDMS) with SDM K041548, K071672, K101690, K151329. Reason for Submission: Introduction of the new patient monitor tCOM+ and its accessories for the previously c… | 2007 |
| * | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSummary page 6…s other than for infant not under gas anesthesia DQA – Oximeter DPZ- Oximeter, Ear Predicate 510(k)s: Sentec Digital Monitoring System (SDMS) with SDM K041548, K071672, K101690, K151329. Reason for Submission: Introduction of the new patient monitor tCOM+ and its accessories for the previously cleared Se… | 2010 |
| * | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Summary page 6…han for infant not under gas anesthesia DQA – Oximeter DPZ- Oximeter, Ear Predicate 510(k)s: Sentec Digital Monitoring System (SDMS) with SDM K041548, K071672, K101690, K151329. Reason for Submission: Introduction of the new patient monitor tCOM+ and its accessories for the previously cleared Sentec Digi… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 9 of the 50 ancestors have a recall of any class.
- 1 other device also cites its predicate K041548.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation. Note: This manual uses the term "system" to refer to any combination of the tCOM+ or SDM and sensors, cables, accessories, disposables, and software. The Sentec Digital Monitoring System is for…
Read the full statement (428 words)
The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.
Note: This manual uses the term "system" to refer to any combination of the tCOM+ or SDM and sensors, cables, accessories, disposables, and software.
The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.
The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor, the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.
Intended patient population: tcPCO2 and tcPO2 monitoring is indicated in adult/pediatric (older than term birth plus 12 months) and neonatal (younger than term birth plus 12 months) patients. Pulse oximetry monitoring is indicated in adult/pediatric patients only.
The target user population: of the Sentec Digital Monitoring System (SDMS) is professional medical personnel, e.g. nurses, physicians, and - if under clinical supervision - lay operators. The correct and safe application of tcPCO2 and tcPO2 measuring equipment require straining of the user (e.g. physiological restrictions, technical aspects such as membrane change, meaning of drift, calibration). Home care providers also require specific training to be allowed to install the SDMS in home environments and to instruct lay persons how to apply the sensors correctly. The lay operator cannot modify the tCOM+ configuration by means of its menu.
Training: Professional medical personnel and instructed home care personnel are trained by Sentec or a qualified and authorized distributor. The instructed home care personnel provide the lay user with the lay user manual and explains attachment and detachment of the sensor. The instructed home care personnel also define the application site for the attachment of the sensor.
Environment of 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. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas. Hospital type facilities typically cover facilities such as surgical centers, special nursing facilities and sleep labs outside of the hospital. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facilities.
The SDMS fulfills the requirements of a non-transit operable and portable device to be used in home environments.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232516: Sentec Digital Monitoring System (SDMS) tCOM+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232516
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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