510(k) · Cleared
ClearedSurgitek (R) Lubri-Flex (TM) Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Engineering Corp. · FAD Stent, Ureteral
Cleared on Mar 13, 1991 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Mar 13, 1991
- Review
- 107 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK905289 Surgitek (R) Lubri-Flex (TM) Ureteral StentMedical Engineering Corp. · 1991
- Descendant · cites it directly · 14 of its ownK961446 AQ Hydrophilic StentCook Urological, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 11 of its ownK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- Descendant · 3 generations on · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · 3 generations on · 1 of its ownK173734 RocaJJ Soft StentsPromepla Sam · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K961446AQ Hydrophilic StentCook Urological, Inc. · 1996 · cites it directly14descendants
- K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · 2 generations on11descendants
- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · 3 generations on5descendants
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · 4 generations on2descendants
- K173734RocaJJ Soft StentsPromepla Sam · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905289 | Surgitek (R) Lubri-Flex (TM) Ureteral Stent | Medical Engineering Corp. | 1991 | — |
| +1 | K961446 | AQ Hydrophilic Stent | Cook Urological, Inc. | 1996 | 18 |
| +2 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| +3 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +4 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +3 | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAD? 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 FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 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?
- Of its descendants, K961446 (Cook Urological, Inc., 1996) has gone furthest, with 14 descendants of its own.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, 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 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K905289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905289: Surgitek (R) Lubri-Flex (TM) Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905289
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026