Cleared Traditional

ECLIPTIS Left Atrial Appendage Exclusion System (ECS135) (K254232) - FDA 510(k) Clearance

Also marketed or referenced as:
ECLIPTIS Left Atrial Appendage Exclusion System (ECS140) ECLIPTIS Left Atrial Appendage Exclusion System (ECS145) ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254232 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
179d
Days
Class 2
Risk

K254232 is an FDA 510(k) clearance for the ECLIPTIS Left Atrial Appendage Exclusion System (ECS135). Classified as Left Atrial Appendage Clip, Implantable (product code PZX), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on June 26, 2026 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences devices

Submission Details

510(k) Number K254232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date June 26, 2026
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZX Left Atrial Appendage Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition Intended To Occlude The Left Atrial Appendage.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PZX Left Atrial Appendage Clip, Implantable

All 9
Devices cleared under the same product code (PZX) and FDA review panel - the closest regulatory comparables to K254232.
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917 · Genesee Biomedical, Inc. · May 2026
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · AtriCure, Inc. · Jan 2025
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · AtriCure, Inc. · Jul 2024
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · AtriCure, Inc. · Nov 2023
LAA Exclusion System
K232295 · Syntheon, LLC · Aug 2023
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · Syntheon · Oct 2022