510(k) · Cleared
ClearedBonee Needle for Bladder Injections, MODELSNBI035, NBI070
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Apr 23, 2009 as substantially equivalent to K022484 (Cook Urological, Inc., 2002) after an 84-day review. Its family tree reaches back 5 generations to 1982. 2 later devices descend from it.
- Decided
- Apr 23, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820973 (1982). 9 ancestors in all, the oldest K812057 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 4 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 3 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 2 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 1 generation backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- This deviceK090217 Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009
- Descendant · cites it directly · 1 of its ownK192498 Single Use InjectorOlympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −4 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −3 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −2 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −1 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| 0 (this device) | K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | Coloplast A/S | 2009 | — |
| +1 | K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K022484 | Cook Injection NeedleSummary page 1…is substantially equivalent in performance, indication, design and materials to Cook Injection Needles from Cook Urological, Inc., cleared under Premarket notification # K022484. Device Description: The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192498 | Single Use Injector | 2020 | 1 |
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?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K192498 (Olympus Medical Systems Corp., 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K022484.
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. 2009, 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?
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090217
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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