510(k) · Cleared
ClearedLAA Exclusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntheon, LLC · PZX Left Atrial Appendage Clip, Implantable
Cleared on Aug 30, 2023 as substantially equivalent to K220305 (Syntheon, 2022) after a 29-day review. Its family tree reaches back 18 generations to 1993. 1 later device descends from it.
- Decided
- Aug 30, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- PZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K933887 (1993). 73 ancestors in all, the oldest K771412 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 14 generations between
- 3 generations backK191413 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2019
- 2 generations backK210293 AtriClip LAA Exclusion SystemAtriCure, Inc. · 2021
- 1 generation backK220305 Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon · 2022
- This deviceK232295 LAA Exclusion SystemSyntheon, LLC · 2023
- Descendant · cites it directly · 0 of its ownK252917 ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 17 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 16 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 15 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 14 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 13 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 12 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 11 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 10 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 9 generations backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- 8 generations backK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- 7 generations backK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
- 6 generations backK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
- 5 generations backK180010 AtriClip FLEX-VAtriCure, Inc. · 2018
- 4 generations backK181474 ArtiClip LAA Exclusion SystemAtriCure, Inc. · 2018
- 3 generations backK191413 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2019
- 2 generations backK210293 AtriClip LAA Exclusion SystemAtriCure, Inc. · 2021
- 1 generation backK220305 Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon · 2022
- This deviceK232295 LAA Exclusion SystemSyntheon, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −17 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −16 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −15 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −14 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −13 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −12 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −11 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −10 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −9 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| −8 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
| −7 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | AtriCure, Inc. | 2016 | — |
| −6 | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. | 2017 | — |
| −5 | K180010 | AtriClip FLEX-V | AtriCure, Inc. | 2018 | — |
| −4 | K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018 | — |
| −3 | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip… | AtriCure, Inc. | 2019 | — |
| −2 | K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021 | — |
| −1 | K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | 2022 | — |
| 0 (this device) | K232295 | LAA Exclusion System | Syntheon, LLC | 2023 | — |
| +1 | K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 PZX? 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 PZX device
- #1 K252917 ATLAAS (Atraumatic Left Atrial Appendage…score 16.8 · 19 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 |
|---|---|---|---|
| * | K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSummary page 4…Left Atrial Appendage Clip, Implantable Review Panel: Cardiovascular Product Class: Class II Product Code: PZX Predicate Device: K220305, Syntheon LAA Exclusion System Device Description: The LAA Exclusion System consists of a single use, sterile, self-closing, im… | 2022 |
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 |
|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | 2026 | 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 30 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 12 of the 73 ancestors have a recall of any class.
- Of its descendants, K252917 (Genesee Biomedical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PZX devicesPZX Left Atrial Appendage Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PZX
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PZX
179in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PZX
No recall names PZX since 2007.
Adverse event reports per year · PZX
43in 2025
MAUDE reports naming product code PZX, 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 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 14 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 1 | — | 0 | 43 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232295: LAA Exclusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232295
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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