510(k) · Cleared
ClearedARCHIMEDES Biodegradable Pancreatic Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 16, 2025 as substantially equivalent to K133700 (Boston Scientific Corporation, 2014) after a 257-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- Jul 16, 2025
- Review
- 257 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K834468 (1984). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK834468 Drainage StentMicrovasive · 1984 · Recalled
- 3 generations backK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- 2 generations backK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- 1 generation backK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
- This deviceK243412 ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2025
- Descendant · cites it directly · 0 of its ownK260835 ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
Most influential descendants
Showing 1 of 1 · See all- K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K834468 | Drainage Stent | Microvasive | 1984 | 2 |
| −3 | K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | Boston Scientific Corp | 1997 | 23 |
| −2 | K101314 | Advanix Biliary Stent with Naviflex RX Delivery System | Boston Scientific Corp | 2010 | — |
| −1 | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… | Boston Scientific Corporation | 2014 | 13 |
| 0 (this device) | K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025 | — |
| +1 | K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Summary page 5…Advanix TM Pancreatic Stent and NaviFlex TM Rapid Exchange (RX) Pancreatic Delivery System and Pushers Clearance number: K133700 Common Name: Stents, Drains, and Dilators for the Biliary Ducts Product Code: FGE Device Class:… | 2014 |
| † | K013784 | Ureteral Stent | 2002 |
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 |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | 2026 | 0 |
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 41 years and passes through 4 companies; a new generation was cleared every 13.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K260835 (Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133700.
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. 2025, 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 ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.
The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.
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/K243412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243412: ARCHIMEDES Biodegradable Pancreatic Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243412
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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