510(k) · Cleared
ClearedNeedle Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 15, 1996 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jul 15, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK961846 Needle CatheterBoston Scientific Corp · 1996
- Descendant · cites it directly · 9 of its ownK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- Descendant · 2 generations on · 7 of its ownK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK212668 Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012864Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825…Boston Scientific Corp · 2001 · cites it directly9descendants
- K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · 2 generations on7descendants
- K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020 · 3 generations on3descendants
- K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961846 | Needle Catheter | Boston Scientific Corp | 1996 | — |
| +1 | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| +2 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| +3 | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +3 | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +4 | K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825… | 2001 | 9 |
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?
- Of its descendants, K012864 (Boston Scientific Corp, 2001) has gone furthest, with 9 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K961846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961846: Needle Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961846
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026