510(k) · Cleared
ClearedDisposable Sclerotherapy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Feb 27, 2020 as substantially equivalent to K171454 (Boston Scientific Corporation, 2017) after a 416-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 27, 2020
- Review
- 416 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961846 (1996). 6 ancestors in all, the oldest K902736 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK961846 Needle CatheterBoston Scientific Corp · 1996
- 2 generations backK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- 1 generation backK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- This deviceK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK212668 Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK232826 Articulator Injection Needle (00711807), Articulator Injection…Steris · 2024
- Descendant · cites it directly · 0 of its ownK232442 Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…Steris · 2024 · 2 generations on0descendants
- K232442Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961846 | Needle Catheter | Boston Scientific Corp | 1996 | — |
| −2 | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| −1 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| 0 (this device) | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +1 | K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
| +2 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle… | Steris | 2024 | — |
| +1 | K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 FBK? 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 FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K171454 | Interject Injection Therapy Needle CatheterSummary page 4…erapy Needle Catheter Common Name: Injection Therapy Needle Catheter Manufacturer: Boston Scientific Corporation 510(k) Number: K171454 Classification: Class II Regulation Number: 876.1500 Regulation Name: Endoscope and accessories P… | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K212668 (Zhejiang Chuangxiang Medical Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K171454.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, 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 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190032 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190032: Disposable Sclerotherapy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190032
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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