510(k) · Cleared
ClearedInjectra Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corp. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 3, 2006 as substantially equivalent to K955558 (Medi-Globe Corp., 1996) after a 62-day review. Its family tree reaches back 1 generation to 1996. 16 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955558 (1996). 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK955558 Gip/Medi-Globe Sclerotherapy NeedlesMedi-Globe Corp. · 1996
- This deviceK061222 Injectra Injection NeedleMedi-Globe Corp. · 2006
- Descendant · cites it directly · 7 of its ownK150434 Injection NeedleMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · cites it directly · 6 of its ownK132065 Injection NeedleEndochoice, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK210917 Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK213914 Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K150434Injection NeedleMicro-Tech (Nanjing) Co., Ltd. · 2015 · cites it directly7descendants
- K132065Injection NeedleEndochoice, Inc. · 2014 · cites it directly6descendants
- K153625Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · 2 generations on4descendants
- K210917Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd. · 2021 · 2 generations on3descendants
- K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955558 | Gip/Medi-Globe Sclerotherapy Needles | Medi-Globe Corp. | 1996 | — |
| 0 (this device) | K061222 | Injectra Injection Needle | Medi-Globe Corp. | 2006 | — |
| +1 | K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +1 | K132065 | Injection Needle | Endochoice, Inc. | 2014 | — |
| +2 | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | 20 |
| +2 | K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| +3 | K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K955558 | Gip/Medi-Globe Sclerotherapy NeedlesSummary page 1…Contact Person's FAX Number: (480) 897-2878 B. Device Name: Injectra Injection Needle C. Predicate Devices: GIP/Medi-Globe Sclerotherapy Needle, (K955558) D. Device Description: The Injectra Injection Needle is a device that is used to deliver solutions into tissues o… | 1996 |
| † | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825… | 2001 |
What descends from it? (16)
See all 163 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?
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 | — |
What is it indicated for?
The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061222: Injectra 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/K061222
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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