510(k) · Cleared
ClearedVeloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corinth Medtech, Inc. · FJL Resectoscope
Cleared on Mar 15, 2019 as substantially equivalent to K162979 (Corinth Medtech, Inc., 2017) after a 52-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 15, 2019
- Review
- 52 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933002 (1994). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 1 generation backK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
- This deviceK190099 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
- Descendant · cites it directly · 0 of its ownK230205 Veloxion SystemCorinth Medtech, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly1descendant
- K250522Multi4 SystemMulti4 Medical AB · 2025 · 2 generations on0descendants
- K230205Veloxion SystemCorinth Medtech, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −2 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −1 | K162979 | Veloxion System | Corinth Medtech, Inc. | 2017 | — |
| 0 (this device) | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +1 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +2 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
| +1 | K230205 | Veloxion System | Corinth Medtech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 FJL? 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 FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K162979 | Veloxion SystemSummary page 4…of the following legally marketed devices as used in combination to which substantial equivalence is claimed: Primary Predicate: Veloxion System (cleared per K162979) Predicate has not been a subject of a design related recall. IV. Device Description The Veloxion System consists of… | 2017 |
What descends from it? (3)
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191341 (Corinth Medtech, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K162979.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, 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 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190099 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190099: Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190099
Report an extraction error
Are you the manufacturer?
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