510(k) Report

510(k) · Cleared

Cleared

AtriClip FLEX-Mini LAA Exclusion System (ACHM)

K234125510(k) TraditionalCleared Jul 29, 2024214-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

AtriCure, Inc. · PZX Left Atrial Appendage Clip, Implantable

Cleared on Jul 29, 2024 after a 214-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 29, 2024
Review
214 days
Class
Class II
Product code
PZX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant cleared2020202220242026
  1. This deviceK234125 AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc. · 2024
  2. Descendant · cites it directly · 0 of its ownK243860 AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc.2024—
+1K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K234125, 2024–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K252917 ATLAAS (Atraumatic Left Atrial Appendage…score 16.8 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.20250

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?

  • Of its descendants, K243860 (AtriCure, Inc., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PZX devices

PZX Left Atrial Appendage Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · PZX

3so far in 2026, the most since 2007

2018: 12019: 12021: 12022: 12023: 22024: 12025: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PZX

179in 2026

2026 (partial year): 179 days median
2007high 179 (2026)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

2021: 102022: 142023: 92024: 352025: 43
2007high 43 (2025) · low 0 (2007)2025

MAUDE reports naming product code PZX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20191—00
20200—00
20211—010
20221—014
20232—09
20241—035
20251—043
202631790—

More from AtriCure, Inc.

97 FDA decisions under this applicant name. See the company

  • K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc. · 2026
  • P100046/S021Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S015EPi- Sense ST Coagulation SystemAtriCure, Inc. · 2026
  • P100046/S020Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S014EPi-Sense and EPi-Sense ST Guided Coagulation SystemAtriCure, Inc. · 2026

Recent decisions in PZX

The PZX category page

  • K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc. · 2026
  • K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System…Edwards Lifesciences · 2026
  • K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc. · 2026
  • K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc. · 2025
  • K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System…AtriCure, Inc. · 2023

https://510kreport.com/device/K234125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K234125: AtriClip FLEX-Mini LAA Exclusion System (ACHM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234125

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026