510(k) · Cleared
ClearedESSENZ Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livanova Deutschland, GmbH · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Nov 10, 2021 as substantially equivalent to K170460 (Sorin Group Deutschland GmbH, 2017) after a 135-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Nov 10, 2021
- Review
- 135 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K941811 (1994). 20 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK113214 Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012
- 2 generations backK131816 Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013
- 1 generation backK170460 Sorin ConnectSorin Group Deutschland GmbH · 2017
- This deviceK212003 ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 4 generations backK012349 Metavision Clinical Information SystemImdsoft, Ltd. · 2002
- 3 generations backK113214 Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012
- 2 generations backK131816 Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013
- 1 generation backK170460 Sorin ConnectSorin Group Deutschland GmbH · 2017
- This deviceK212003 ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −4 | K012349 | Metavision Clinical Information System | Imdsoft, Ltd. | 2002 | — |
| −3 | K113214 | Tlink Data Management System (DMS) | Terumo Cardiovascular Systems Corp. | 2012 | — |
| −2 | K131816 | Sorin Connect Data Management System | Sorin Group Deutschland GmbH | 2013 | — |
| −1 | K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017 | — |
| 0 (this device) | K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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 DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 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 |
|---|---|---|---|
| * | K170460 | Sorin ConnectSummary page 5…on The modified ESSENZ Patient Monitor is substantially equivalent in function and intended use to the Sorin CONNECT cleared in Premarket Notification K170460. Indications for Use The device is a modularly structured program package that is exclusively used with LivaNova… | 2017 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 20 ancestors have a recall of any class.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ESSENZ Patient Monitor is a modularly structured program package that is exclusively used with LivaNova Heart-Lung Machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212003: ESSENZ Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212003
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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