510(k) · Cleared
Recalled · Class II · 2013Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Designs, LLC · JXG Shunt, Central Nervous System And Components
Cleared on Nov 17, 2004 as substantially equivalent to K002970 (Medical Designs, LLC, 2000) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 17, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915546 (1991). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915546 PS Medical Ventriculostomy KitPudenz-Schulte Medical Research Corp. · 1991 · Recalled
- This deviceK042359 Subdural Evacuating Port System Cranial Access Kit (Seps-CA)…Medical Designs, LLC · 2004
- Descendant · cites it directly · 0 of its ownK252514 Evac-MriPhasor Health, LLC · 2025
- Descendant · cites it directly · 0 of its ownK241458 Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915546 | PS Medical Ventriculostomy Kit | Pudenz-Schulte Medical Research Corp. | 1991 | 1 |
| 0 (this device) | K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)… | Medical Designs, LLC | 2004 | — |
| +1 | K252514 | Evac-Mri | Phasor Health, LLC | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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? (3)
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 |
|---|---|---|---|
| * | K002970 | Subdural Evacuating Port System, Model 11-9901Summary page 1…CFR 878.4680, and 21 CFR 878.4014. 3. Predicate Devices: 1. Subdural Evacuating Port System Kit, Medical Designs, LLC, Catalog # 11-9901 (# K002970). 2. Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46156, (#K91 5546). 3. Ventriculostomny Kit, Medtronic… | 2000 |
| * | K915546 | PS Medical Ventriculostomy KitSummary page 1…ural Evacuating Port System Kit, Medical Designs, LLC, Catalog # 11-9901 (# K002970). 2. Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46156, (#K91 5546). 3. Ventriculostomny Kit, Medtronic Neurosurgery, Catalog # 46154, (#K915546). 4. Cranial Access Kit, Integra Neur… | 1991 |
| * | — | Cranial Access Kit Named without a submission number |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2013 | Class II | Z-0551-2014 | Labeling mix-ups | Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K252514 (Phasor Health, LLC, 2025) has gone furthest, with 0 descendants of its own.
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.
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?
Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042359
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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