510(k) · Cleared
ClearedOlympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Aug 10, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 10, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011484 Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1Olympus Optical Co., Ltd. · 2001
- Descendant · cites it directly · 4 of its ownK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK213914 Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK252021 Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max…Olympus Medical Systems Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK232200 Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153625Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016 · cites it directly4descendants
- K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022 · 2 generations on2descendants
- K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd. · 2025 · 3 generations on0descendants
- K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K232200Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011484 | Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | Olympus Optical Co., Ltd. | 2001 | — |
| +1 | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | 20 |
| +2 | K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
| +3 | K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025 | — |
| +2 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single… | Olympus Medical Systems Corporation | 2025 | — |
| +3 | K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (6)
2 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, K153625 (Olympus Medical Systems Corp., 2016) has gone furthest, with 4 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/K011484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011484: Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011484
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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