510(k) · Cleared
ClearedResolve Biliary Locking Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 26, 2014 as substantially equivalent to K121832 (Merit Medical Systems, Inc., 2012) after a 182-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Nov 26, 2014
- Review
- 182 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981344 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK981344 Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
- 2 generations backK063733 Resolve Biliary Drainage CatheterMerit Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK121832 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2012 · Recalled
- This deviceK141408 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic Coating | Uresil Corp. | 1998 | — |
| −2 | K063733 | Resolve Biliary Drainage Catheter | Merit Medical Systems, Inc. | 2007 | 4 |
| −1 | K121832 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2012 | 1 |
| 0 (this device) | K141408 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2014 | — |
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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | K121832 | Resolve Biliary Locking Drainage CatheterSummary page 4…Catheter Predicate Device Classification Name: Catheter, Biliary, Diagnostic Premarket Notification: K121832 Manufacturer: Merit Medical Systems, Inc. Class II Classificatio… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The ReSolve Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141408: Resolve Biliary Locking Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141408
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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