510(k) · Cleared
ClearedETHICON LINX® Esophagus Sizing Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Torax Medical, Inc. · QJN Laparoscopic Accessories, Esophageal Sizing
Cleared on Feb 9, 2023 as substantially equivalent to K201035 (Torax Medical, Inc., 2020) after a 28-day review. Its family tree reaches back 8 generations to 2008.
- Decided
- Feb 9, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN070003 (2008). No later device cites it as a predicate yet.
- Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 4 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 3 generations backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- 2 generations backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- 1 generation backK201035 ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc. · 2020
- This deviceK230089 ETHICON LINX® Esophagus Sizing ToolTorax Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −7 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −6 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −5 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −4 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −3 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| −2 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| −1 | K201035 | ETHICON Linx Esophagus Sizing Tool | Torax Medical, Inc. | 2020 | — |
| 0 (this device) | K230089 | ETHICON LINX® Esophagus Sizing Tool | Torax Medical, Inc. | 2023 | — |
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 QJN? 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 QJN device
- #1 K201035 ETHICON Linx Esophagus Sizing Toolscore 4.5 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K201035 | ETHICON Linx Esophagus Sizing ToolSummary page 4…lassification (Product) Code: QJN Predicate Device: ETHICON LINX® Esophagus Sizing Tool K201035, cleared 09 July 2020 Device Description The LINX Esophagus Sizing Tool is a sterile, single-use device that is used as an acces… | 2020 |
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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All QJN devicesQJN Laparoscopic Accessories, Esophageal Sizing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QJN
Too few QJN 510(k)s in any year since 2007 to give a median.
Recalls per year · QJN
No recall names QJN since 2007.
Adverse event reports per year · QJN
1in 2024
MAUDE reports naming product code QJN, 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230089: ETHICON LINX® Esophagus Sizing Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230089
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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