510(k) · Cleared
ClearedDisposable Endoscope Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yangzhou Fartley Medical Instrument Technology Co., Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Aug 19, 2022 as substantially equivalent to K171454 (Boston Scientific Corporation, 2017) after a 199-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Aug 19, 2022
- Review
- 199 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). 1 later device descends from it, 1 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 deviceK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK241595 EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd. · 2025 · 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) | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +1 | K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2025 | 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…ion Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Product Code: FBK 5.3 Predicate Device Device Name: Interject™ Injection Therapy Needle Catheter K171454 Manufacturer: Boston Scientific Corporation Classification Name: Endoscopic Injection Needle, Gastroenterology-Urology Regulat… | 2017 |
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 |
|---|---|---|---|
| K241595 | EzVu Visual Vasopressor injector (EV-19) | 2025 | 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 26 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, K241595 (Veol Medical Technologies Pvt, Ltd., 2025) has gone furthest, with 0 descendants 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. 2022, 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 Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa
to:
* introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding
lesions in the digestive system;
* aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
* control non-variceal hemorrhage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220292: Disposable Endoscope Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220292
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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