510(k) · Cleared

Cleared

Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855

K012052510(k) TraditionalCleared Feb 11, 2002224-day reviewClass II21 CFR 882.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic PS Medical · JXG Shunt, Central Nervous System And Components

Cleared on Feb 11, 2002 as substantially equivalent to K974739 (Johnson & Johnson Professionals, Inc., 1998) and 4 other predicates after a 224-day review. Its family tree reaches back 3 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it.

Decided: Feb 11, 2002
Review: 224 days
Class: Class II
Product code: JXG
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K944222 (1995). 8 ancestors in all, the oldest K861377 (1986). 25 later devices descend from it, 6 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
2 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
1 generation backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
This deviceK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
Descendant · cites it directly · 23 of its ownK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
Descendant · cites it directly · 19 of its ownK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
Descendant · cites it directly · 7 of its ownK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
Descendant · 2 generations on · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
Descendant · 3 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2004high 3 (2004) · low 0 (2014)2026

Class I recalls in this family

K152700 StrataMR Valves and Shunts2 generations on · 2016

Most influential descendants

Showing 5 of 25 · See all

K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery · 2004 · cites it directly23descendants
K042465PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · cites it directly19descendants
K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · cites it directly7descendants
K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · 2 generations on6descendants
K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K944222	Codman-Medos Valve Shunt System	Johnson & Johnson Professionals, Inc.	1995	—
−2	K973774	Codman Hakim Micro Precision Valve	Johnson & Johnson Professionals, Inc.	1997	—
−1	K980778	Hakim Micro Programmable Valve System	Johnson & Johnson Professionals, Inc.	1998	—
0 (this device)	K012052	Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855	Medtronic PS Medical	2002	—
+1	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
+1	K060681	Medtronic PS Medical Strata Type Value	Medtronic Neurosurgery	2006	2
+2	K062009	Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T	Aesculap, Inc.	2007	—
+3	K103003	Aesculap- Meithke Progav Programmable Shunt System	Aesculap, Inc.	2010	5

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1990	1	0
1995	1	0
1998	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	2	0
2006	1	0
2007	1	0
2008	2	0
2009	1	0
2010	2	0
2011	2	0
2012	2	0
2013	1	0
2015	2	0
2016	1	1
2017	1	0
2018	2	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K012052, 1995–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K974739	Hakim Programmable Valve System Summary page 1 …fication Name: Central Nervous System Fluid Shunts and Components, 21 CFR 882.5550 Predicate Device Identification: 1.Johnson & Johnson Hakim Programmable Valve System (K974739), Johnson & Johnson Hakim Micro Programmable Valve System (K980778). Substantial equivalence is based upon materials, design, pe…	Johnson & Johnson Professionals, Inc.	1998	—
*	K980778	Hakim Micro Programmable Valve System Summary page 1 …1 CFR 882.5550 Predicate Device Identification: 1.Johnson & Johnson Hakim Programmable Valve System (K974739), Johnson & Johnson Hakim Micro Programmable Valve System (K980778). Substantial equivalence is based upon materials, design, performance specifications and intended use. 2.Sophysa Pressure Adjus…	Johnson & Johnson Professionals, Inc.	1998	—
*	K992465	Sophy SU8 Pressure Adjustable Valve Summary page 1 …alve System (K980778). Substantial equivalence is based upon materials, design, performance specifications and intended use. 2.Sophysa Pressure Adjustable Valve System (K992465). Substantial equivalence is based upon design, performance specifications and intended use. 3.Medtronic PS Medical Delta-CSF Fl…	Sophysa SA	2000	—
*	K902783	PS Medical Delta CSF-Flow Control Valve Summary page 1 …Valve System (K992465). Substantial equivalence is based upon design, performance specifications and intended use. 3.Medtronic PS Medical Delta-CSF Flow Control Valve (K902783). Substantial equivalence is based upon materials, performance specifications, design and intended use. 4.Medtronic PS Medical B…	Pudenz-Schulte Medical Research Corp.	1990	5
*	K951258	PS Medical Bioglide CSF-Flow Control Shunt Kit Summary page 1 …2783). Substantial equivalence is based upon materials, performance specifications, design and intended use. 4.Medtronic PS Medical BioGlide CSF Flow Control Shunt Kit (K951258). Identical material and manufacturing process used for surface modification of the product Description: The STRATA™ Valve incor…	Pudenz-Schulte Medical Research Corp.	1995	31
†	K900676	CSF-Flow Control Valve, Cylindrical & Shunt Kit	Pudenz-Schulte Medical Research Corp.	1990	—
†	K792007	CSF-Ventricular Catheter, Standard Des	Pudenz-Schulte Medical Research Corp.	1980	31
†	K792005	CSF-Cardiac/Peritoneal Catheter	Pudenz-Schulte Medical Research Corp.	1980	1

Also cleared against K974739: 9 other devices →

What descends from it? (25)

See all 25

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033850	Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide	Medtronic Neurosurgery	2004	23
K042465	PS Medical Strata II Valve	Medtronic Neurosurgery	2004	19
K060681	Medtronic PS Medical Strata Type Value	Medtronic Neurosurgery	2006	7
K052386	Medtronic M2 Magnet Adjustment Tool	Medtronic Neurosurgery	2005	0
K041992	Medtronic Stratavarius	Medtronic Neurosurgery	2005	0
K042198	PS Medical Neurosurgical Implants	Medtronic Neurosurgery	2004	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
2 of the 8 ancestors have a recall of any class.
Of its descendants, K033850 (Medtronic Neurosurgery, 2004) has gone furthest, with 23 descendants of its own.
9 other devices also cite its predicate K974739.

How does its category compare?

All JXG devices

JXG 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

2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007high 276 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JXG

3in 2024

2007high 30 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXG

1,198in 2025

2007high 1,484 (2018) · low 629 (2009)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™ Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool.

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/K012052 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012052

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026