510(k) · Cleared
ClearedSentEP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentiar, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 18, 2020 as substantially equivalent to K173274 (Ceevra, Inc., 2018) after a 344-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 344 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 1 generation backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- This deviceK192890 SentEPSentiar, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK223290 CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073468 MimicsMaterialise NV · 2008
- 6 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 5 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 4 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 1 generation backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- This deviceK192890 SentEPSentiar, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073468 | Mimics | Materialise NV | 2008 | — |
| −6 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −5 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −4 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −3 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −2 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| −1 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| 0 (this device) | K192890 | SentEP | Sentiar, Inc. | 2020 | — |
| +1 | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K173274 | Ceevra Reveal 2.0Summary page 4…system display at the same time. PREDICATE/REFERENCE DEVICE INFORMATION Predicate Ceevra Reveal 2.0 cleared via K173274 on July 10, 2018 Device Reference Abbott EnSite Velocity System cleared via K130594 on M… | 2018 |
| † | K130594 | Ensite Velocity System | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | 2023 | 0 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K223290 (Sentiar, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K173274.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The SentEP system is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192890: SentEP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192890
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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