510(k) · Cleared
ClearedAtriClip PRO-Mini LAA Exclusion System (PROM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · PZX Left Atrial Appendage Clip, Implantable
Cleared on Jan 15, 2025 as substantially equivalent to K234125 (AtriCure, Inc., 2024) after a 30-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 15, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- PZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K234125 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK234125 AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc. · 2024
- This deviceK243860 AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024 | — |
| 0 (this device) | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)Summary page 5…Product Code: PZX Classification Panel: Cardiovascular Predicate Device: AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125, July 29, 2024) Reference Device: AtriClip LAA Exclusion System with Preloaded G… | 2024 |
| † | K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | 2016 |
| † | K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) | 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?
- Its one ancestor has no recall.
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. 2025, 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 AtriClip 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 other appropriate viewing technologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243860: AtriClip PRO-Mini LAA Exclusion System (PROM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243860
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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