510(k) · Cleared
ClearedRepris Bladder Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uro-1, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on May 3, 2018 as substantially equivalent to K090830 (Laborie Medical Technologies, Ltd., 2009) after a 98-day review. Its family tree reaches back 6 generations to 1982. 1 later device descends from it.
- Decided
- May 3, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K820973 (1982). 11 ancestors in all, the oldest K812057 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 5 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 4 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 3 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 2 generations backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- 1 generation backK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
- This deviceK180214 Repris Bladder Injection SystemUro-1, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK253598 InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −5 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −4 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −3 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −2 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| −1 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
| 0 (this device) | K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018 | — |
| +1 | K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipSummary page 4…Gastroenterology-Urology Regulatory Class: II III. PREDICATE DEVICE injeTAK Adjustable Tip Needle. K090830 Note: This predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253598 | InjecSURE Injection System | 2026 | 0 |
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 36 years and passes through 7 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K253598 (Carbon Medical Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090830.
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. 2018, 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 Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180214: Repris Bladder Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180214
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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