510(k) · Cleared
ClearedNavigator HD Ureteral Access Sheath Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Dec 12, 2012 as substantially equivalent to K022135 (Boston Scientific Corp, 2002) and 1 other predicate after a 104-day review. Its family tree reaches back 1 generation to 2002. 24 later devices descend from it.
- Decided
- Dec 12, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022135 (2002). 2 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- This deviceK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- Descendant · cites it directly · 21 of its ownK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- Descendant · 2 generations on · 19 of its ownK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 5 of its ownK230748 Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
- Descendant · 3 generations on · 4 of its ownK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K140323Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014 · cites it directly21descendants
- K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016 · 2 generations on19descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 3 generations on7descendants
- K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023 · 3 generations on5descendants
- K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| +1 | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| +2 | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +3 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +3 | K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
| +3 | K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2020 | 3 | 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? (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 |
|---|---|---|---|
| * | K022135 | Ureteral Access Sheath Set (Uass)Summary page 1…Classification Name: KOD - Catheter, Urological 21 CFR 876.5130, Class 11 Premarket Notification' Boston Scientific, K022 135 (9/13/2002) and K030956 (5/23/2003) E. Device Description The Navigator Tm HD Ureteral Ac… | 2002 |
| * | K030956 | Navigator Ureteral Access Sheath SetSummary page 1…: KOD - Catheter, Urological 21 CFR 876.5130, Class 11 Premarket Notification' Boston Scientific, K022 135 (9/13/2002) and K030956 (5/23/2003) E. Device Description The Navigator Tm HD Ureteral Access Sheath Set is desig… | 2003 |
What descends from it? (24)
See all 242 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. 2012, 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 UASS 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/K122649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122649: Navigator HD Ureteral Access Sheath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122649
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