510(k) · Cleared
ClearedSiphonguard CSF Control Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Apr 7, 2000 as substantially equivalent to K902783 (Pudenz-Schulte Medical Research Corp., 1990) after a 284-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.
- Decided
- Apr 7, 2000
- Review
- 284 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902783 (1990). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK902783 PS Medical Delta CSF-Flow Control ValvePudenz-Schulte Medical Research Corp. · 1990 · Recalled
- This deviceK992173 Siphonguard CSF Control DeviceJohnson & Johnson Professionals, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK053350 Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK122118 Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002 · cites it directly8descendants
- K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006 · 2 generations on5descendants
- K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012 · cites it directly4descendants
- K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · cites it directly3descendants
- K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902783 | PS Medical Delta CSF-Flow Control Valve | Pudenz-Schulte Medical Research Corp. | 1990 | 5 |
| 0 (this device) | K992173 | Siphonguard CSF Control Device | Johnson & Johnson Professionals, Inc. | 2000 | — |
| +1 | K020667 | Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2002 | — |
| +2 | K053350 | Modification to Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2006 | — |
| +1 | K122118 | Hakim Programmable and Precision Valve Shunt System | Codman & Shurtleff, Inc. | 2012 | — |
| +1 | K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Codman & Shurtleff, Inc. | 2017 | 1 |
| +2 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | Integra Lifesciences Production Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K902783 | PS Medical Delta CSF-Flow Control ValveSummary page 2…quivalence of the SiphonGuard™ CSF Control Device to predicate products, is substantiated by its similarity in intended use, design, and performance to the Delta® Valve (K902783), and Transguard™ device (pre- amendment), as well as by the use of the identical materials used in the CODMAN HAKIM™ Micro Preci… | 1990 |
| * | — | Transguard™ device Named without a submission number | |
| † | K973774 | Codman Hakim Micro Precision Valve | 1997 |
What descends from it? (9)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.
The SiphonGuard™ device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992173: Siphonguard CSF Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992173
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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