510(k) · Cleared
ClearedDisposable Injection Needle AF series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alton (Shanghai) Medical Instruments Co., Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Sep 27, 2023 as substantially equivalent to K210917 (Anrei Medical (Hangzhou) Co., Ltd., 2021) after a 177-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Sep 27, 2023
- Review
- 177 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955558 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK955558 Gip/Medi-Globe Sclerotherapy NeedlesMedi-Globe Corp. · 1996
- 3 generations backK061222 Injectra Injection NeedleMedi-Globe Corp. · 2006
- 2 generations backK150434 Injection NeedleMicro-Tech (Nanjing) Co., Ltd. · 2015
- 1 generation backK210917 Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. · 2021
- This deviceK230925 Disposable Injection Needle AF seriesAlton (Shanghai) Medical Instruments Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955558 | Gip/Medi-Globe Sclerotherapy Needles | Medi-Globe Corp. | 1996 | — |
| −3 | K061222 | Injectra Injection Needle | Medi-Globe Corp. | 2006 | — |
| −2 | K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| −1 | K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| 0 (this device) | K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K210917 | Single Use Injection NeedleSummary page 5…y Product Code Description: Endoscopic Injection Needle, Gastroenterology-Urology Product code: FBK III. Identification of Predicate device Predicate Submission Number: K210917 Trade/Device Name: Single Use Injection Needle Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regu… | 2021 |
| † | K212668 | Sclerotherapy Needle | 2022 |
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 27 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K210917.
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. 2023, 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 Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the Gl tract.
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/K230925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230925: Disposable Injection Needle AF series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230925
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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