510(k) · Cleared
Recalled · Class II · 2016Sentec Digital Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Sep 12, 2007 as substantially equivalent to K041548 (Sentec, Inc., 2004) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 12, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915699 (1993). 12 ancestors in all, the oldest K890299 (1989). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915699 Nellcor Portable Pulse Oximeter Model N-20Nellcor, Inc. · 1993
- 3 generations backK963707 Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996
- 2 generations backK972468 NPB-195 Pulse OximeterNellcor Puritan Bennett, Inc. · 1997
- 1 generation backK041548 Sentec Digital Monitor Model #SDMSentec, Inc. · 2004 · Recalled
- This deviceK071672 Sentec Digital Monitoring SystemSentec AG · 2007
- Descendant · cites it directly · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK162014 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small…Bluepoint Medical GmbH & Co. KG · 2017
Most influential descendants
Showing 4 of 4 · See all- K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · cites it directly3descendants
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 2 generations on1descendant
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915699 | Nellcor Portable Pulse Oximeter Model N-20 | Nellcor, Inc. | 1993 | — |
| −3 | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40) | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K972468 | NPB-195 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 1997 | — |
| −1 | K041548 | Sentec Digital Monitor Model #SDM | Sentec, Inc. | 2004 | 9 |
| 0 (this device) | K071672 | Sentec Digital Monitoring System | Sentec AG | 2007 | — |
| +1 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| +2 | 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 | — |
| +2 | 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 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 1…Manufacturer Comment This device is predicate for PCO2, SpO 2, and PR K041548 SenTec AG monitoring using the ear lobe as monitoring site in System… | 2004 |
| * | K063434 | Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemSummary page 1…These devices are predicate for PCO2 only monitoring using the new Mu/ti-Site Attachment Ring K063434 TOSCA 500 tcPCO2, SpO2 Radiometer Basel AG to attach the V-Sign Sensor to the patient. and PR monitoring s… | 2007 |
| * | K991644 | Microgas 7650 Transcutaneous MonitorSummary page 1…ts. K964MicroGas K99164 7650 Microoa 7650 s tor Linde Medical Sensors The "Adhesive Ring 32 mm" cleared in K991644 is Transcutaneous Monitor predicate for the usage of the Multi-Site Attachment… | 1999 |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K101690 (Sentec AG, 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041548.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
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…
Read the full statement (292 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071672: Sentec Digital Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071672
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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