510(k) · Cleared
Recalled · Class II · 2017Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · JXG Shunt, Central Nervous System And Components
Cleared on Aug 27, 2008 as substantially equivalent to K033850 (Medtronic Neurosurgery, 2004) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 27, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K944222 (1995). 13 ancestors in all, the oldest K831678 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 4 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 2 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 1 generation backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- This deviceK082127 Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635Medtronic Neurosurgery · 2008
- Descendant · cites it directly · 0 of its ownK083076 Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt…Medtronic Neurosurgery · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K083076Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836Medtronic Neurosurgery · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −4 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −2 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −1 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| 0 (this device) | K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635 | Medtronic Neurosurgery | 2008 | — |
| +1 | K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model… | Medtronic Neurosurgery | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide Our reading of the summary gave K038850, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Medtronic PS Medical Strata NSC Valve and Shunt Assemblies”. | 2004 |
| * | K042465 | PS Medical Strata II ValveSummary page 1…edtronic PS Medical Strata IIValves and Shunt Assemblies with and without BioGlide (K042465) * CSF-Flow Control Valve, Burr Hole (K831678… | 2004 |
| * | K831678 | P-S Medical CSF-Flow Control Valve-BurSummary page 1…BioGlide (K042465) * CSF-Flow Control Valve, Burr Hole (K831678) Description: The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured o… | 1983 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2017 | Class II | Z-1121-2017 | Other | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K083076 (Medtronic Neurosurgery, 2008) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K033850.
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. 2008, 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 Strata NSC Burr Hole Valves and Shunt Assemblies are shunt components designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata NSC Burr Hole Valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation inorder to address changing patient needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082127: Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082127
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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