510(k) · Cleared

Cleared

PS Medical Neurosurgical Implants

K042198510(k) SpecialCleared Sep 24, 200442-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 Neurosurgery · JXG Shunt, Central Nervous System And Components

Cleared on Sep 24, 2004 as substantially equivalent to K803257 (Pudenz-Schulte Medical Research Corp., 1981) and 15 other predicates after a 42-day review. Its family tree reaches back 5 generations to 1995.

Decided: Sep 24, 2004
Review: 42 days
Class: Class II
Product code: JXG
Recalls: None
Predicates: 16

Its longest line of descent runs back 5 generations to K944222 (1995). 22 ancestors in all, the oldest K803257 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
4 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
3 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
2 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
1 generation backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
This deviceK042198 PS Medical Neurosurgical ImplantsMedtronic Neurosurgery · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K944222	Codman-Medos Valve Shunt System	Johnson & Johnson Professionals, Inc.	1995	—
−4	K973774	Codman Hakim Micro Precision Valve	Johnson & Johnson Professionals, Inc.	1997	—
−3	K980778	Hakim Micro Programmable Valve System	Johnson & Johnson Professionals, Inc.	1998	—
−2	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
0 (this device)	K042198	PS Medical Neurosurgical Implants	Medtronic Neurosurgery	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1984	2	0
1986	1	0
1987	1	0
1988	2	0
1990	2	0
1991	1	0
1993	1	0
1994	1	0
1995	1	0
1998	1	0
2000	2	0

FIG. 1 — Lineage of K042198, 1995–2004Source: 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.

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

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What was it cleared against? (16)

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
*	K803257	CSG-Flow Control Valve Summary page 1 …s and Accessories ( 882.5550) Predicate Device Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468,…	Pudenz-Schulte Medical Research Corp.	1981	—
*	K831678	P-S Medical CSF-Flow Control Valve-Bur Summary page 1 …essories ( 882.5550) Predicate Device Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K9134…	Pudenz-Schulte Medical Research Corp.	1983	1
*	K841442	P-S Medical CSF-Flow Control Valve- Summary page 1 …( 882.5550) Predicate Device Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412,…	P-S Medical	1984	2
*	K833822	P-S Medical CSF Access Dev 15MM/25MM Summary page 1 …0) Predicate Device Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412,…	Pudenz-Schulte Medical Research Corp.	1984	—
*	K873247	CSF-Flow Control Valve, Ultra Small Summary page 1 …ate Device Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412,…	Pudenz-Schulte Medical Research Corp.	1987	1
*	K874468	P-S Medical Ventricular Access Port Summary page 1 …ce Identification: PS MedicaKlh Neurosurgical implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412,…	Pudenz-Schulte Medical Research Corp.	1988	—
*	K874498	CSF-Ventriculostomy Reservoir Summary page 1 …cal implants (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K0338…	Pudenz-Schulte Medical Research Corp.	1988	29
*	K900676	CSF-Flow Control Valve, Cylindrical & Shunt Kit Summary page 1 …nts (K803257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) De…	Pudenz-Schulte Medical Research Corp.	1990	—
*	K902783	PS Medical Delta CSF-Flow Control Valve Summary page 1 …257, K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description…	Pudenz-Schulte Medical Research Corp.	1990	5
*	K911410	PS Medical Button Valve Summary page 1 …K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The P…	Pudenz-Schulte Medical Research Corp.	1991	—
*	K913412	PS Medical CSF-Access Device Summary page 1 …K831678, K841442, K833822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical…	Pudenz-Schulte Medical Research Corp.	1993	—
*	K934545	PS Medical Delta Burr Hole Valve Summary page 1 …822,K1873247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical Neurosurgical Implants are manufactured with silicone adhes…	Pudenz-Schulte Medical Research Corp.	1994	—
*	K951258	PS Medical Bioglide CSF-Flow Control Shunt Kit Summary page 1 …247, K874468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The…	Pudenz-Schulte Medical Research Corp.	1995	31
*	K991502	Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022 Summary page 1 …468, K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The devices a…	Medtronic PS Medical	2000	—
*	K012052	Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 Summary page 1 …K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The devices are used a…	Medtronic PS Medical	2002	—
*	K033850	Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide Summary page 1 …K874498, K900676, K902783, K911410, K913412, K934545, K951258, K991502, K012052, K033850.) Description: The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The devices are used as shunt c…	Medtronic Neurosurgery	2004	2

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
7 of the 22 ancestors have a recall of any class.

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?

CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042198: PS Medical Neurosurgical Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042198

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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