510(k) · Cleared
ClearedRE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM
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 Jul 24, 2014 as substantially equivalent to K102485 (Coloplast A/S, 2010) after a 142-day review. Its family tree reaches back 1 generation to 2010. 5 later devices descend from it.
- Decided
- Jul 24, 2014
- Review
- 142 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102485 (2010). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK102485 RE-Trace Ureteral Access SheathColoplast A/S · 2010
- This deviceK140523 RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length…Coloplast A/S · 2014
- Descendant · cites it directly · 2 of its ownK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
- Descendant · cites it directly · 1 of its ownK181811 ReTrace Ureteral Access SheathColoplast A/S · 2018
- Descendant · 2 generations on · 0 of its ownK250132 Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242173 Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12…Coloplast Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
Most influential descendants
Showing 5 of 5 · See all- K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated · 2017 · cites it directly2descendants
- K181811ReTrace Ureteral Access SheathColoplast A/S · 2018 · cites it directly1descendant
- K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…Coloplast Corp. · 2024 · 2 generations on0descendants
- K182403Peel-Away IntroducerCook Incorporated · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102485 | RE-Trace Ureteral Access Sheath | Coloplast A/S | 2010 | — |
| 0 (this device) | K140523 | RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM | Coloplast A/S | 2014 | — |
| +1 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral… | Cook Incorporated | 2017 | — |
| +1 | K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | 2018 | — |
| +2 | K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025 | — |
| +2 | K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10… | Coloplast Corp. | 2024 | — |
| +2 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K102485 | RE-Trace Ureteral Access SheathSummary page 1…Access Sheath is substantially equivalent in performaznce, indication, design and materials to Re-Trace Ureteral Access Sheath, cleared Linder Prernarket notification II K 102485. K140523… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2014, 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 Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscapic procedures facilitating the passage of cndoscopes and other instruments into the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140523: RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140523
Report an extraction error
Are you the manufacturer?
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