510(k) · Cleared
Recalled · Class II · 2013Resolve 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 Jul 17, 2012 as substantially equivalent to K063733 (Merit Medical Systems, Inc., 2007) after a 25-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 17, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981344 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981344 Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
- 1 generation backK063733 Resolve Biliary Drainage CatheterMerit Medical Systems, Inc. · 2007 · Recalled
- This deviceK121832 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK141408 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141408Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic Coating | Uresil Corp. | 1998 | — |
| −1 | K063733 | Resolve Biliary Drainage Catheter | Merit Medical Systems, Inc. | 2007 | 4 |
| 0 (this device) | K121832 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2012 | — |
| +1 | K141408 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 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 |
|---|---|---|---|
| * | K063733 | Resolve Biliary Drainage CatheterSummary page 1…Common/NJuaI Name: Biliary Drainage Catheter Predicae Classification Name: Catheter, Biliary, Diagnostic Device Premarket Notification: K063733 Manufacturer: Merit Medical Systems, Inc. Class 11 Classification… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141408 | Resolve Biliary Locking Drainage Catheter | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2013 | Class II | Z-0866-2013 | Nonconforming Material/Component | A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K141408 (Merit Medical Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
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. 2012, 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 Locking Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121832: 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/K121832
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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