510(k) · Cleared
ClearedVeloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corinth Medtech, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Jun 6, 2019 as substantially equivalent to K190113 (Corinth Medtech, Inc., 2019) after a 20-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 6, 2019
- Review
- 20 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933002 (1994). 11 ancestors in all, the oldest K897003 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 4 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 3 generations backK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
- 2 generations backK180752 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device…Corinth Medtech, Inc. · 2018
- 1 generation backK190113 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- This deviceK191335 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −4 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −3 | K162979 | Veloxion System | Corinth Medtech, Inc. | 2017 | — |
| −2 | K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit… | Corinth Medtech, Inc. | 2018 | — |
| −1 | K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| 0 (this device) | K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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 |
|---|---|---|---|
| * | K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Summary page 4…Manufacturer Predicate Device Names 510(k)# Clearance Date Primary Predicate Corinth MedTech, Inc. Veloxion System K190113 April 24, 2019 Predicate device has not been the subject of a design related recall. IV. Device Description The V… | 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 25 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation via suction channel under continuous flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191335: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191335
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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