510(k) · Cleared
ClearedSingle-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 24, 2026 as substantially equivalent to K180418 (Micro-Tech (Nanjing) Co., Ltd., 2018) after a 267-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jun 24, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K974788 (1998). 8 ancestors in all, the oldest K910931 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- 5 generations backK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- 4 generations backK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- 3 generations backK151671 Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015
- 2 generations backK162226 Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017
- 1 generation backK180418 Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018
- This deviceK253393 Single-use Balloon Dilatation Catheter (AG-5251-083018…Hangzhou AGS MedTech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| −5 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| −4 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| −3 | K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| −2 | K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| −1 | K180418 | Reliant (TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| 0 (this device) | K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518… | Hangzhou AGS MedTech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K180418 | Reliant (TM) Multistage Dilatation Balloon CatheterSummary page 5…e: Reliant(TM) Multistage Dilatation Balloon Catheter Common Name: Reliant(TM) Multistage Dilatation Balloon Catheter 510(k) Number: K180418 Regulation class: Class II Regulation Number: 876.5010 Regulation Description: Biliary catheter and accessories… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K180418.
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. 2026, 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 Single-use Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract (involving biliary tract). The device is supplied sterile and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253393: Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253393
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026