510(k) · Cleared
Recalled · Class II · 2023Sentec Digital Monitor Model #SDM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentec, Inc. · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Aug 9, 2004 as substantially equivalent to K991644 (Linde Medical Sensors AG, 1999) and 2 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1993. 5 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 9, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- LKD
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915699 (1993). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK915699 Nellcor Portable Pulse Oximeter Model N-20Nellcor, Inc. · 1993
- 2 generations backK963707 Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996
- 1 generation backK972468 NPB-195 Pulse OximeterNellcor Puritan Bennett, Inc. · 1997
- This deviceK041548 Sentec Digital Monitor Model #SDMSentec, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK071672 Sentec Digital Monitoring SystemSentec AG · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- Descendant · 3 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 · 3 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 5 of 5 · See all- K071672Sentec Digital Monitoring SystemSentec AG · 2007 · cites it directly4descendants
- K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · 2 generations on3descendants
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 3 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 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915699 | Nellcor Portable Pulse Oximeter Model N-20 | Nellcor, Inc. | 1993 | — |
| −2 | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40) | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K972468 | NPB-195 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 1997 | — |
| 0 (this device) | K041548 | Sentec Digital Monitor Model #SDM | Sentec, Inc. | 2004 | — |
| +1 | K071672 | Sentec Digital Monitoring System | Sentec AG | 2007 | 1 |
| +2 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| +3 | 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 | — |
| +3 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K991644 | Microgas 7650 Transcutaneous MonitorSummary page 1…Medical Sensors These two devices are exactly the same devices Transcutaneous Monitor (refer to 510k summary of K991644). Between the Linde MicroGas 7650 (K991644) and the Kontro… | 1999 |
| * | P810037 | Kontron Cutaneous PCO2 Monitor FDA lists this PMA only through its supplements; the earliest we hold is P810037/S001 (Sep 16, 1982). Summary page 1…Linde MicroGas 7650 (K991644) and the Kontron MicroGas 7650 (P 810037/S007) are only labeling differences. P810037 MicroGas 76… | |
| * | K972468 | NPB-195 Pulse OximeterSummary page 1…to the PCO2 part of the Sentec Digital Monitor System. K972468 NPB-195 Pulse Oximeter Nellcor Puritan Bennett Inc. These two devices are predicate devices to the… | 1997 |
| * | — | Dura-Y Oxygen Transducer, Ear Clip Named without a submission number |
What descends from it? (5)
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 |
|---|---|---|---|---|
| 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. |
| May 2, 2023 | Class II | Z-1980-2023 | Device Design | 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 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 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K071672 (Sentec AG, 2007) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K991644.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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…
Read the full statement (176 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041548: Sentec Digital Monitor Model #SDM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041548
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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