510(k) · Cleared
ClearedNM Injection Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Aug 24, 1990 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Aug 24, 1990
- Review
- 64 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK902736 NM Injection NeedlesOlympus Corp. · 1990
- Descendant · cites it directly · 7 of its ownK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- Descendant · cites it directly · 4 of its ownK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK190032 Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK213914 Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK220292 Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · cites it directly7descendants
- K153625Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · cites it directly4descendants
- K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd. · 2020 · 2 generations on3descendants
- K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022 · 2 generations on2descendants
- K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902736 | NM Injection Needles | Olympus Corp. | 1990 | — |
| +1 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| +1 | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | 20 |
| +2 | K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +2 | K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
| +2 | K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (13)
See all 132 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?
- Of its descendants, K171454 (Boston Scientific Corporation, 2017) has gone furthest, with 7 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/K902736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902736: NM 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/K902736
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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