510(k) · Cleared
ClearedMulti4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multi4 Medical AB · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Jun 27, 2025 as substantially equivalent to K191341 (Corinth Medtech, Inc., 2019) and 1 other predicate after a 126-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Jun 27, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K820973 (1982). 27 ancestors in all, the oldest K812057 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 6 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 5 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 4 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 3 generations backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- 2 generations backK090217 Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009
- 1 generation backK192498 Single Use InjectorOlympus Medical Systems Corp. · 2020
- This deviceK250522 Multi4 SystemMulti4 Medical AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −6 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −5 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −4 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −3 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| −2 | K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | Coloplast A/S | 2009 | — |
| −1 | K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020 | — |
| 0 (this device) | 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 |
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 FAS? 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 FAS device
- #1 K251403 Dornier Bi-Polar Electrode BIP12CLM Bipolar…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Summary page 5…ION The Multi4 System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate K191341 Veloxion System / Corinth MedTech, Inc. Primary K192498 Single Use Injection / Olympus Me… | 2019 |
| * | K192498 | Single Use InjectorSummary page 5…Number Predicate Device Name / Manufacturer Predicate K191341 Veloxion System / Corinth MedTech, Inc. Primary K192498 Single Use Injection / Olympus Medical Systems Secondary The predicate devices have not been subject to a desig… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 8 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 27 ancestors have a recall of any class.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.
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/K250522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250522: Multi4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250522
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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