510(k) · Cleared

Cleared

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

K152897510(k) TraditionalCleared Mar 4, 2016155-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

Integra LifeSciences Corporation · JXG Shunt, Central Nervous System And Components

Cleared on Mar 4, 2016 as substantially equivalent to K861377 (Cordis Corp., 1986) and 3 other predicates after a 155-day review. Its family tree reaches back 1 generation to 1986.

Decided: Mar 4, 2016
Review: 155 days
Class: Class II
Product code: JXG
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K861377 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK861377 Standard/Pediatric Cordis Hydrocephalus ValvesCordis Corp. · 1986
This deviceK152897 Integra DP Valve Systems (including Burr Hole Reservoirs and…Integra LifeSciences Corporation · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K861377	Standard/Pediatric Cordis Hydrocephalus Valves	Cordis Corp.	1986	—
0 (this device)	K152897	Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel…	Integra LifeSciences Corporation	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	2	0

FIG. 1 — Lineage of K152897, 1986–2016Source: 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? (4)

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
*	K861377	Standard/Pediatric Cordis Hydrocephalus Valves Summary page 4 …XG 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Integra DP™ Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors); K861377 Omnishunt System for Ventricular Shunting: K903844 Polypropylene Burr Hole Reservoir; K925810 Gravity Compensating Accessory; K93…	Cordis Corp.	1986	—
*	K903844	Omnishunt System for Ventricular Shunting Summary page 4 …ich equivalence is claimed Integra DP™ Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors); K861377 Omnishunt System for Ventricular Shunting: K903844 Polypropylene Burr Hole Reservoir; K925810 Gravity Compensating Accessory; K932429 807.92(a)(4) - Device descript…	Cordis Corp.	1990	—
*	K925810	Cordis Polypropylene Burr Hole Reservoir Summary page 4 …ve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors); K861377 Omnishunt System for Ventricular Shunting: K903844 Polypropylene Burr Hole Reservoir; K925810 Gravity Compensating Accessory; K932429 807.92(a)(4) - Device description The Integra DP™ Valve Systems are impla…	Cordis Corp.	1994	—
*	K932429	Cordis Gravity Compensating Accessory Summary page 4 …rs and Stainless Steel Connectors); K861377 Omnishunt System for Ventricular Shunting: K903844 Polypropylene Burr Hole Reservoir; K925810 Gravity Compensating Accessory; K932429 807.92(a)(4) - Device description The Integra DP™ Valve Systems are implantable central nervous system fluid shun…	Cordis Corp.	1994	1

Also cleared against K861377: 2 other devices →

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?

1 of the 4 ancestors has a recall of any class.
2 other devices also cite its predicate K861377.

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. 2016, this device’s year, is highlighted.

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?

Integra DP Valve Systems Integra DP Valve Systems are implantable devices which serve as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of…

Read the full statement (180 words)

Integra DP Valve Systems

Integra DP Valve Systems are implantable devices which serve as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions.

Burr Hole Reservoirs

Hydrocephalus valve components are elements used in the implantation of hydrocephalus valve systems. In addition, the burr hole reservoir may be used in conjunction with a ventricular catheter to access ventricular CSF.

Gravity Compensating Accessory

The Gravity Compensating Accessory is an implantable device which is implanted in series with a hydrocephalus valve to control cerebrospinal fluid (CSF) drainage from the cerebral ventricles to an appropriate drainage site. It is designed to minimize the excessive reduction in intraventricular pressure (relative to atmosphere) and CSF volume caused by the "pull" exerted by the fluid column within the outflow catheter when the patient is sitting or standing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152897 · printed Nov 4, 2026

Cite this page

510(k) Report. “K152897: Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152897

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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