510(k) · Cleared
Recalled · 2008Resolve Biliary 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 14, 2007 as substantially equivalent to K981344 (Uresil Corp., 1998) after a 331-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 14, 2007
- Review
- 331 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981344 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK981344 Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
- This deviceK063733 Resolve Biliary Drainage CatheterMerit Medical Systems, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK121832 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK141408 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic Coating | Uresil Corp. | 1998 | — |
| 0 (this device) | K063733 | Resolve Biliary Drainage Catheter | Merit Medical Systems, Inc. | 2007 | — |
| +1 | K121832 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2012 | 1 |
| +2 | K141408 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingSummary page 1…Class II Classification Panel Number 876 Product Code FGE Clearance Status K981344 Manufacturer Uresil L.P. Registration Number 1450395… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121832 | Resolve Biliary Locking Drainage Catheter | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2008 | Not classified | Z-0611-2009 | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. |
| Nov 7, 2008 | Not classified | Z-0613-2009 | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. |
| Nov 7, 2008 | Not classified | Z-0614-2009 | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. |
| Nov 7, 2008 | Not classified | Z-0612-2009 | Other | Biliary drainage catheter tips may separate from the catheter shaft after placement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K121832 (Merit Medical Systems, Inc., 2012) has gone furthest, with 1 descendant 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. 2007, 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 as stated in the FDA summary.
https://510kreport.com/device/K063733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063733: Resolve Biliary 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/K063733
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