510(k) · Cleared
Recalled · Class II · 2021Single Use Injector NM600/610
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Feb 12, 2016 as substantially equivalent to K011484 (Olympus Optical Co., Ltd., 2001) and 2 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it. It has been recalled 20 times.
- Decided
- Feb 12, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- FBK
- Recalls
- 20
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955558 (1996). 5 ancestors in all, the oldest K902736 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955558 Gip/Medi-Globe Sclerotherapy NeedlesMedi-Globe Corp. · 1996
- 2 generations backK061222 Injectra Injection NeedleMedi-Globe Corp. · 2006
- 1 generation backK132065 Injection NeedleEndochoice, Inc. · 2014
- This deviceK153625 Single Use Injector NM600/610Olympus Medical Systems Corp. · 2016
- Descendant · cites it directly · 2 of its ownK213914 Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK252021 Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max…Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK232200 Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022 · cites it directly2descendants
- K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd. · 2025 · 2 generations on0descendants
- K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K232200Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955558 | Gip/Medi-Globe Sclerotherapy Needles | Medi-Globe Corp. | 1996 | — |
| −2 | K061222 | Injectra Injection Needle | Medi-Globe Corp. | 2006 | — |
| −1 | K132065 | Injection Needle | Endochoice, Inc. | 2014 | — |
| 0 (this device) | K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016 | — |
| +1 | K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
| +2 | K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025 | — |
| +1 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single… | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K011484 | Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1Summary page 6…Device Trade Common Name Applicant 510(k) No. Name Olympus Injector OLYMPUS OPTICAL Co., K011484 Injector Ltd. NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1, NM-4U-1, NM-4Z-1 NM Injection Steri… | 2001 |
| * | K902736 | NM Injection NeedlesSummary page 6…Ltd. NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1, NM-4U-1, NM-4Z-1 NM Injection Sterile OLYMPUS Corporation. K902736 Needles Injection Needle Injection Injection ENDOCHOICE, INC. K… | 1990 |
| * | K132065 | Injection NeedleSummary page 6…US Corporation. K902736 Needles Injection Needle Injection Injection ENDOCHOICE, INC. K132065 Needle Needle 5.4 Device Description This instrument has been designed to be used with an Olympus endoscope to p… | 2014 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-1032-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1038-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1041-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1043-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1047-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1030-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1046-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1049-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1033-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1037-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1040-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1042-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1048-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1031-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1034-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1035-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1036-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1039-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1044-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1045-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K213914 (Jiangsu Vedkang Medical Science and Technology Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K011484.
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. 2016, 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 instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153625: Single Use Injector NM600/610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153625
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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