510(k) · Cleared
Recalled · Class II · 2026SureFlo EVD Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkis Biosciences, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Aug 31, 2017 as substantially equivalent to K972994 (Integra Neurocare, LLC, 1997) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 1986. It has been recalled once.
- Decided
- Aug 31, 2017
- Review
- 183 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864676 (1986). 6 ancestors in all, the oldest K800168 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| −1 | K972994 | External CSF Drainage Management Systems | Integra Neurocare, LLC | 1997 | — |
| 0 (this device) | K170599 | SureFlo EVD Catheter | Arkis Biosciences, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K972994 | External CSF Drainage Management SystemsSummary page 4…duct Code JXG Classification Name Shunt, Central Nervous System and Components Predicate Device(s): Primary Predicate: TraumaCath, Integra NeuroSiciences (K972994) Predicate: Neurocath Ag, Vygon Neuro, (K081942) Reference Device: NMI… | 1997 |
| * | K081942 | Neurocath AGSummary page 4…ponents Predicate Device(s): Primary Predicate: TraumaCath, Integra NeuroSiciences (K972994) Predicate: Neurocath Ag, Vygon Neuro, (K081942) Reference Device: NMI PICC III, Navilyst Medical (K121089) Performance Performance standar… | 2008 |
| † | K121089 | Nmi Picc Iii | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2026 | Class II | Z-2173-2026 | Process control | Out-of-specification endotoxin result that did not meet the acceptance criteria. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K972994.
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. 2017, 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 SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170599: SureFlo EVD Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170599
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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