510(k) · Cleared
Recalled · 2009Catheters, Biliary Catheters, Urological
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FFA Tube, Drainage, Suprapubic
Cleared on Dec 8, 1994 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 8, 1994
- Review
- 97 days
- Class
- Class II
- Product code
- FFA
- Recalls
- 5
- Predicates
- 0
27 later devices descend from it, 5 citing it directly.
- This deviceK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994
- Descendant · cites it directly · 17 of its ownK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
- Descendant · 2 generations on · 14 of its ownK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 5 of its ownK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · cites it directly17descendants
- K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010 · 2 generations on14descendants
- K093392Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · cites it directly5descendants
- K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation · 2014 · 3 generations on4descendants
- K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944290 | Catheters, Biliary Catheters, Urological | Boston Scientific Corp | 1994 | — |
| +1 | 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 | K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Navilyst Medical, Inc. | 2009 | 3 |
| +3 | K133700 | Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… | Boston Scientific Corporation | 2014 | 13 |
| +3 | K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 FFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K965147 | Biliary Stent, Biliary Stent System, Biliary Endoprosthesis | 1997 | 17 |
| K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | 2009 | 5 |
| K141335 | Expel Apd Drainage Catheter System | 2014 | 1 |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL… | 2022 | 0 |
| K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2009 | Not classified | Z-1340-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1333-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1332-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Mar 18, 2009 | Not classified | Z-1331-2009 | Labeling False and Misleading | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and… |
| Sep 21, 2006 | Not classified | Z-0081-2007 | Other | Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K965147 (Boston Scientific Corp, 1997) has gone furthest, with 17 descendants of its own.
How does its category compare?
All FFA devicesFFA Tube, Drainage, Suprapubic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFA
FDA has decided no FFA device since 2007.
Median 510(k) review, days · FFA
Too few FFA 510(k)s in any year since 2007 to give a median.
Recalls per year · FFA
4in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFA
27in 2025
MAUDE reports naming product code FFA, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 4 | 36 |
| 2010 | 0 | — | 0 | 47 |
| 2011 | 0 | — | 0 | 49 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 78 |
| 2016 | 0 | — | 0 | 51 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944290: Catheters, Biliary Catheters, Urological.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944290
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026