510(k) · Cleared
Clearedesolution® Esophageal Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S4 Medical Corp. · QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Cleared on Nov 9, 2024 as substantially equivalent to DEN230006 (S4 Medical Corp., 2023) after a 31-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Nov 9, 2024
- Review
- 31 days
- Class
- Class II
- Product code
- QXU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230006 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230006 esolutionS4 Medical Corp. · 2023
- This deviceK243233 esolution® Esophageal RetractorS4 Medical Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230006 | esolution | S4 Medical Corp. | 2023 | — |
| 0 (this device) | K243233 | esolution® Esophageal Retractor | S4 Medical Corp. | 2024 | — |
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 QXU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN230006 | esolutionSummary page 5…Device Name 510(k) Number Procode Class esolution® Esophageal S4 Medical Corp. DEN230006 QXU II Retractor Page 1 of… | 2023 |
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 QXU devicesQXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QXU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QXU
Too few QXU 510(k)s in any year since 2007 to give a median.
Recalls per year · QXU
No recall names QXU since 2007.
Adverse event reports per year · QXU
No MAUDE report names QXU since 2007.
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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243233 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243233: esolution® Esophageal Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243233
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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