510(k) · Cleared
ClearedVeloxion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corinth Medtech, Inc. · FJL Resectoscope
Cleared on Feb 24, 2023 as substantially equivalent to K190099 (Corinth Medtech, Inc., 2019) after a 30-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Feb 24, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933002 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 2 generations backK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
- 1 generation backK190099 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion…Corinth Medtech, Inc. · 2019
- This deviceK230205 Veloxion SystemCorinth Medtech, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −3 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −2 | K162979 | Veloxion System | Corinth Medtech, Inc. | 2017 | — |
| −1 | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| 0 (this device) | K230205 | Veloxion System | Corinth Medtech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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
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 |
|---|---|---|---|
| * | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…Summary page 4…the following legally marketed devices as used in combination to which substantial equivalence is claimed: Primary Predicate: Veloxion System (cleared per K190099) Predicate has not been a subject of a design related recall. IV. Device Description The Veloxion System consists of… | 2019 |
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 29 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K190099.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K230205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230205: Veloxion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230205
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