510(k) · Cleared
ClearedNavigator HD Ureteral Access Sheath Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Mar 7, 2014 as substantially equivalent to K122649 (Boston Scientific Corp, 2012) after a 25-day review. Its family tree reaches back 2 generations to 2002. 21 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 25 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022135 (2002). 3 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 1 generation backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- This deviceK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- Descendant · cites it directly · 19 of its ownK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK230748 Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
- Descendant · 2 generations on · 4 of its ownK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK241181 Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −1 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| +1 | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +2 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +2 | K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
| +2 | K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021 | — |
| +3 | K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K122649 | Navigator HD Ureteral Access Sheath SetSummary page 1…Gastroenterology-Urology 21 CFR 876.1500, Class 11 Premarket Notification: Boston Scientific, K 122649 (12/12/2012) F. Device Description The Navigator TM HD Ureteral Access Sheath Set is designed to provide the physici… | 2012 |
What descends from it? (21)
See all 212 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a 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 K122649.
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 Navigator™ HD Ureteral Access Sheath Set is indicated for use in endoscopic procedures to facilitate the passage, of endoscopes, urological instruments and for the injection of fluids into the urinary tract
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140323: Navigator HD Ureteral Access Sheath Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140323
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