510(k) · Cleared
ClearedMultipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jan 14, 2011 as substantially equivalent to K093392 (Navilyst Medical, Inc., 2009) after a 59-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 14, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944290 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944290 Catheters, Biliary Catheters, UrologicalBoston Scientific Corp · 1994 · Recalled
- 1 generation backK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · Recalled
- This deviceK103353 Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter…Navilyst Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK111315 Multipurpose Drainage CatheterNavilyst Medical, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111315Multipurpose Drainage CatheterNavilyst Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944290 | Catheters, Biliary Catheters, Urological | Boston Scientific Corp | 1994 | 5 |
| −1 | K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Navilyst Medical, Inc. | 2009 | 3 |
| 0 (this device) | K103353 | Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary… | Navilyst Medical, Inc. | 2011 | — |
| +1 | K111315 | Multipurpose Drainage Catheter | Navilyst Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K093392 | Multipurpose, Nephrostomy and Biliary Drainage CathetersSummary page 1…FGE-Biliary Catheter and Accessories 21CFR§8h9.5010, Class 11 Premdrket Notification(s): K093392 LJE-Catheter, Nephrostomy, General & Plastic… | 2009 |
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 |
|---|---|---|---|
| K111315 | Multipurpose Drainage Catheter | 2011 | 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 17 years and passes through 2 companies; a new generation was cleared every 15.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K111315 (Navilyst Medical, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K093392.
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. 2011, 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?
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air
from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary,
nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid
collections in the urinary system.
Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103353: Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; 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/K103353
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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