510(k) · Decided
Recalled · Class II · 2024APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FAD Stent, Ureteral
Cleared on Nov 10, 2022 as substantially equivalent to K924608 (Boston Scientific Corp, 1994) and 1 other predicate after a 506-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 5 times.
- Decided
- Nov 10, 2022
- Review
- 506 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924608 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- This deviceK211934 APDL Drainage Catheter System, Flexima APDL Drainage Catheter…Boston Scientific Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| 0 (this device) | K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima… | Boston Scientific Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 FAD? 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 FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 10…catheter and accessories III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device K924608 Hydrogel Coated Percuflex Drainage Catheters K944290 Modified (Flexima) Hydrogel Coated Drainage Catheters For devices that ar… | 1994 |
| * | K944290 | Catheters, Biliary Catheters, UrologicalSummary page 10…accessories III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device K924608 Hydrogel Coated Percuflex Drainage Catheters K944290 Modified (Flexima) Hydrogel Coated Drainage Catheters For devices that are manufactured with Flexima resin (Tecoflex), K944290… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2024 | Class II | Z-3147-2024 | Packaging process control | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| Jul 18, 2024 | Class II | Z-3149-2024 | Packaging process control | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| Jul 18, 2024 | Class II | Z-3150-2024 | Packaging process control | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| Jul 18, 2024 | Class II | Z-3148-2024 | Packaging process control | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| Jul 18, 2024 | Class II | Z-3151-2024 | Packaging process control | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 7 other devices also cite its predicate K924608.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, 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 | 1 | — | 1 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, hematomas, seromas, urinomas, or any loculated fluid collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211934: APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211934
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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