510(k) · Cleared
ClearedEssenz HLM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livanova Deutschland, GmbH · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Mar 9, 2023 as substantially equivalent to K210130 (Livanova Deutschland, GmbH, 2021) and 2 other predicates after a 301-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Mar 9, 2023
- Review
- 301 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915183 (1992). 16 ancestors in all, the oldest K871131 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 3 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 2 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 1 generation backK082344 Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH · 2008 · Recalled
- This deviceK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
- Descendant · cites it directly · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −3 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −2 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −1 | K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | Sorin Group Deutschland GmbH | 2008 | 1 |
| 0 (this device) | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
| +1 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2021 | 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 DTQ? 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 DTQ device
- #1 K221895 Terumo Advanced Perfusion System 1score 7.3 · 8 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 |
|---|---|---|---|
| * | K210130 | Stockert S5 SystemSummary page 5…Codes: Device Class: Class II III. PREDICATE DEVICE INFORMATION Primary predicate: • Stöckert S5 System, Heart-Lung Machine (K210130) Secondary predicates: • Sorin Centrifugal Pump 5 (CP5) (K112225) • Electrical Venous Occluder (EVO) (K082344)… | 2021 |
| * | K112225 | Sorin Centrifugal Pump 5 (CP5)Summary page 5…E DEVICE INFORMATION Primary predicate: • Stöckert S5 System, Heart-Lung Machine (K210130) Secondary predicates: • Sorin Centrifugal Pump 5 (CP5) (K112225) • Electrical Venous Occluder (EVO) (K082344) IV. INDICATIONS FOR USE Essenz HLM is intended to be used during card… | 2011 |
| * | K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Summary page 5…Stöckert S5 System, Heart-Lung Machine (K210130) Secondary predicates: • Sorin Centrifugal Pump 5 (CP5) (K112225) • Electrical Venous Occluder (EVO) (K082344) IV. INDICATIONS FOR USE Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) h… | 2008 |
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 |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | 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 31 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K232291 (Livanova Deutschland, GmbH, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, 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 | 2 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221373: Essenz HLM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221373
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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