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 Mar 24, 2017 as substantially equivalent to K042523 (Richard Wolf Medical Instruments Corp., 2005) and 1 other predicate after a 149-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Mar 24, 2017
- Review
- 149 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933002 (1994). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 1 generation backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- This deviceK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK190099 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK180752 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device…Corinth Medtech, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK190113 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly3descendants
- K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…Corinth Medtech, Inc. · 2018 · cites it directly2descendants
- K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly1descendant
- K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 2 generations on1descendant
- K250522Multi4 SystemMulti4 Medical AB · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −1 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| 0 (this device) | K162979 | Veloxion System | Corinth Medtech, Inc. | 2017 | — |
| +1 | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +1 | K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit… | Corinth Medtech, Inc. | 2018 | — |
| +1 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +2 | K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +2 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 4 | 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? (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 |
|---|---|---|---|
| * | K042523 | Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, AccessoriesSummary page 4…in combination to which substantial equivalence is claimed: Primary Predicate: Richard Wolf Resection Pump and Resectoscope for Chip Aspiration (K042523) Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886)… | 2005 |
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 4…nd Resectoscope for Chip Aspiration (K042523) Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886) Page 5-1 SECTION 5: 510(k) Summary… | 2002 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion… | 2019 | 3 |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid… | 2018 | 2 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion… | 2019 | 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 23 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190099 (Corinth Medtech, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K042523.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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/K162979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162979: Veloxion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162979
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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