510(k) Report

510(k) · Cleared

Cleared

RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access Sheath, 12/14 CH-FR, Length 35CM, UR

K123675510(k) TraditionalCleared Mar 1, 201391-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coloplast A/S · FED Endoscopic Access Overtube, Gastroenterology-Urology

Cleared on Mar 1, 2013 as substantially equivalent to K102485 (Coloplast A/S, 2010) after a 91-day review. Its family tree reaches back 1 generation to 2010. 22 later devices descend from it.

Decided
Mar 1, 2013
Review
91 days
Class
Class II
Product code
FED
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K102485 (2010). 22 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2024: 3 descendants cleared2025: 8 descendants cleared2020: 2 descendants cleared2026: 3 descendants cleared2022: 1 descendant clearedReference device: K043418 · Cook Pediatric Flexor Ureteral Access Shealth · Cook Urological, Inc. · 2005 · recalledK102485 · RE-Trace Ureteral Access Sheath · Coloplast A/S · 20102010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 5 descendants K102485 · RE-Trace Ureteral Access Sheath · Coloplast A/S · 20100
  1. Root · 1 generation backK102485 RE-Trace Ureteral Access SheathColoplast A/S · 2010
  2. This deviceK123675 RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM…Coloplast A/S · 2013
  3. Descendant · cites it directly · 19 of its ownK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
  4. Descendant · 2 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
  5. Descendant · 2 generations on · 5 of its ownK230748 Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
  6. Descendant · 2 generations on · 4 of its ownK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
  7. Descendant · 3 generations on · 2 of its ownK241181 Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2016: 22018: 12020: 22021: 12022: 12023: 12024: 32025: 82026: 3
2016high 8 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 22 · See all
  • K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016 · cites it directly19descendants
  • K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 2 generations on7descendants
  • K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023 · 2 generations on5descendants
  • K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021 · 2 generations on4descendants
  • K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K102485RE-Trace Ureteral Access SheathColoplast A/S2010—
0 (this device)K123675RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral…Coloplast A/S2013—
+1K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.2016—
+2K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.2016—
+2K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan)2023—
+2K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd.2021—
+3K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201810
202020
202110
202210
202310
202430
202580
202630
FIG. 1 — Lineage of K123675, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K102485RE-Trace Ureteral Access Sheath
Summary page 1
…lly equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath 12/14 Ch/Fr from Coloplast A/S, cleared under Premarket notification # K 102485. Description of the Device: The Re-Trace Ureteral Access Sheath 10/12 ChfFr & Ureteral Access Sheath are line ex…
Coloplast A/S2010—
†K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc.20051

Also cleared against K102485: 1 other device →

What descends from it? (22)

See all 22

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.201619
K181811ReTrace Ureteral Access SheathColoplast A/S20181

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.
  • Of its descendants, K151084 (Well Lead Medical Co., Ltd., 2016) has gone furthest, with 19 descendants of its own.
  • 1 other device also cites its predicate K102485.

How does its category compare?

All FED devices

FED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FED

11in 2025

2007: 12008: 12009: 42010: 32011: 12012: 42013: 22014: 42015: 22016: 52017: 12018: 42019: 52020: 42021: 32022: 12023: 32024: 62025: 112026 (partial year): 6
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FED

120in 2025

2009: 90 days median2010: 90 days median2012: 82 days median2014: 123 days median2016: 126 days median2018: 122 days median2019: 94 days median2020: 117 days median2021: 189 days median2023: 138 days median2024: 98 days median2025: 120 days median2026 (partial year): 67 days median
2007high 189 (2021) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FED

4in 2024

2007: 12013: 32024: 4, 4 Class I
2007high 4 (2024) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · FED

115in 2025

2007: 142008: 182009: 192010: 192011: 202012: 352013: 252014: 342015: 352016: 292017: 322018: 342019: 302020: 332021: 552022: 362023: 532024: 642025: 115
2007high 115 (2025) · low 14 (2007)2025

MAUDE reports naming product code FED, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—114
20081—018
2009490019
2010390019
20111—020
2012482035
20132—325
20144123034
20152—035
20165126029
20171—032
20184122034
2019594030
20204117033
20213189055
20221—036
20233138053
20246984 (4)64
2025111200115
20266670—

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 as stated in the FDA summary.

Also cleared against K102485

1 other device cites the same predicate.

  • K140523RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CMColoplast A/S · 2014

More from Coloplast A/S

71 FDA decisions under this applicant name. See the company

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018

Recent decisions in FED

The FED category page

  • K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
  • K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
  • K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
  • K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
  • K260965CVAC Aspiration SystemCalyxo, Inc. · 2026

https://510kreport.com/device/K123675 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123675: RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access Sheath, 12/14 CH-FR, Length 35CM, UR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123675

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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