510(k) · Cleared
ClearedReTrace Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 7, 2018 as substantially equivalent to K140523 (Coloplast A/S, 2014) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 2010. 1 later device descends from it.
- Decided
- Sep 7, 2018
- Review
- 63 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K102485 (2010). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK102485 RE-Trace Ureteral Access SheathColoplast A/S · 2010
- 1 generation backK123675 RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM…Coloplast A/S · 2013
- This deviceK181811 ReTrace Ureteral Access SheathColoplast A/S · 2018
- Descendant · cites it directly · 0 of its ownK242173 Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12…Coloplast Corp. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…Coloplast Corp. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102485 | RE-Trace Ureteral Access Sheath | Coloplast A/S | 2010 | — |
| −1 | K123675 | RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral… | Coloplast A/S | 2013 | — |
| 0 (this device) | K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K140523 | RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CMSummary page 4…substantially equivalent in performance, indication, design, and materials to the Coloplast’s own predicate device, ReTrace Ureteral Access Sheaths cleared under 510(k) K140523 and K123675. These predicates have not been subject to a design-related recall. No reference devices were used in this submissio… | 2014 |
| * | K123675 | RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access…Summary page 4…ly equivalent in performance, indication, design, and materials to the Coloplast’s own predicate device, ReTrace Ureteral Access Sheaths cleared under 510(k) K140523 and K123675. These predicates have not been subject to a design-related recall. No reference devices were used in this submission.… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10… | 2024 | 0 |
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 8 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K242173 (Coloplast Corp., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140523.
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. 2018, 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?
The ReTrace Ureteral Access Sheath is used 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/K181811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181811: ReTrace Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181811
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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