510(k) · Cleared
ClearedRetrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Nov 12, 2024 as substantially equivalent to K181811 (Coloplast A/S, 2018) after a 111-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Nov 12, 2024
- Review
- 111 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K102485 (2010). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK102485 RE-Trace Ureteral Access SheathColoplast A/S · 2010
- 2 generations backK123675 RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM…Coloplast A/S · 2013
- 1 generation backK181811 ReTrace Ureteral Access SheathColoplast A/S · 2018
- This deviceK242173 Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12…Coloplast Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K102485 | RE-Trace Ureteral Access Sheath | Coloplast A/S | 2010 | — |
| −2 | K123675 | RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral… | Coloplast A/S | 2013 | — |
| −1 | K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | 2018 | — |
| 0 (this device) | K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10… | Coloplast Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K181811 | ReTrace Ureteral Access SheathSummary page 5…ogy III. PREDICATE DEVICE Primary Predicate: ReTrace Ureteral Access Sheath 510(k) Holder: Coloplast A/S 510(k) Number: K181811 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2018 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
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/K242173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242173: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242173
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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