510(k) · Cleared
ClearedDisposable Endoscopic Injection Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou New Med Micro-Medtech Co., Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Dec 2, 2025 as substantially equivalent to K213914 (Jiangsu Vedkang Medical Science and Technology Co., Ltd., 2022) after a 155-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 2, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K955558 (1996). 7 ancestors in all, the oldest K902736 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK955558 Gip/Medi-Globe Sclerotherapy NeedlesMedi-Globe Corp. · 1996
- 4 generations backK061222 Injectra Injection NeedleMedi-Globe Corp. · 2006
- 3 generations backK132065 Injection NeedleEndochoice, Inc. · 2014
- 2 generations backK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · Recalled
- 1 generation backK213914 Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
- This deviceK252021 Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955558 | Gip/Medi-Globe Sclerotherapy Needles | Medi-Globe Corp. | 1996 | — |
| −4 | K061222 | Injectra Injection Needle | Medi-Globe Corp. | 2006 | — |
| −3 | K132065 | Injection Needle | Endochoice, Inc. | 2014 | — |
| −2 | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | 20 |
| −1 | K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K213914 | Injection NeedleSummary page 5…500 Regulatory Class: Class II Product code: FBK Review Panel: Gastroenterology/Urology III. Predicate Devices 510(k) Number: K213914 Trade name: Injection Needle Common name: Endoscope and accessories Classification: Class II Pr… | 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 29 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K213914.
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. 2025, 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?
This product is intended to be used in conjunction with an endoscope for the submucosal injection in the digestive tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252021: Disposable Endoscopic Injection Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252021
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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