510(k) · Cleared
ClearedBorvo EVAC System (Ergo); Borvo EVAC System (Classic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Borvo Medical, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Aug 20, 2024 as substantially equivalent to K042359 (Medical Designs, LLC, 2004) after an 89-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 20, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915546 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK915546 PS Medical Ventriculostomy KitPudenz-Schulte Medical Research Corp. · 1991 · Recalled
- 1 generation backK042359 Subdural Evacuating Port System Cranial Access Kit (Seps-CA)…Medical Designs, LLC · 2004 · Recalled
- This deviceK241458 Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915546 | PS Medical Ventriculostomy Kit | Pudenz-Schulte Medical Research Corp. | 1991 | 1 |
| −1 | K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)… | Medical Designs, LLC | 2004 | 1 |
| 0 (this device) | K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 JXG? 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 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 |
|---|---|---|---|
| * | K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Summary page 5…Number: 21 CFR 882.5550 Regulatory Class: II Product Code: JXG 1.3 Predicate Device Medtronic SEPS Cranial Access Kit (K042359) 1.4 Device Description The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is de… | 2004 |
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 33 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K042359.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241458: Borvo EVAC System (Ergo); Borvo EVAC System (Classic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241458
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