510(k) · Cleared
Recalled · Class II · 2024Sensis Vibe (VD15)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 15, 2023 as substantially equivalent to K150493 (Siemens Medi Cal Solutions, Inc., 2015) and 1 other predicate after a 269-day review. Its family tree reaches back 8 generations to 2001. It has been recalled 3 times.
- Decided
- Sep 15, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003122 (2001). 43 ancestors in all, the oldest K862740 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 7 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 6 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 5 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 4 generations backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- 3 generations backK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- 2 generations backK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- 1 generation backK191008 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · Recalled
- This deviceK223812 Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −7 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −6 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −5 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −4 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| −3 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| −2 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| −1 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 1 |
| 0 (this device) | K223812 | Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K150493 | SensisSummary page 4…CCK 4. Legally Marketed Primary Predicate Device Trade Name: Sensis Vibe (VC12) 510(k) Clearance K150493 Clearance Date June 30, 2015 Classification Name: Programmable diagnostic computer Classifi… | 2015 |
| * | K191008 | iLab Polaris Multi-Modality Guidance SystemSummary page 5…by any of the applicable issues. Predicate Device Trade Name: iLab Polaris-Modality Guidance System 510(k) Clearance K191008 Clearance Date July 02, 2019 Classification Name: Programmable diagnostic computer C… | 2019 |
| † | K051217 | Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2024 | Class II | Z-2438-2024 | Software design | If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash. |
| Jul 3, 2024 | Class II | Z-2441-2024 | Software design | If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash. |
| Nov 29, 2023 | Class II | Z-0683-2024 | Software design | The possibility of the Sensis documentation functionality application to crash. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 7 of the 43 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to…
Read the full statement (131 words)
The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools.
The device is intended to be used on either or both of the following populations:
1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223812: Sensis Vibe (VD15).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223812
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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