510(k) Report

510(k) · Cleared

Recalled · 2009

CSF-Ventriculostomy Reservoir

K874498510(k) TraditionalCleared Feb 11, 1988101-day reviewClass II21 CFR 882.5550Recalls 29

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

Pudenz-Schulte Medical Research Corp. · LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular

Cleared on Feb 11, 1988 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 29 times.

Decided
Feb 11, 1988
Review
101 days
Class
Class II
Product code
LKG
Recalls
29
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK874498 CSF-Ventriculostomy ReservoirPudenz-Schulte Medical Research Corp. · 1988
  2. Descendant · cites it directly · 0 of its ownK063836 Rivulet Ventricular and Snap Shunt and Convertible Ventricular…Medtronic Neurosurgery · 2007
  3. Descendant · cites it directly · 0 of its ownK042198 PS Medical Neurosurgical ImplantsMedtronic Neurosurgery · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K063836Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701…Medtronic Neurosurgery · 2007 · cites it directly0descendants
  • K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874498CSF-Ventriculostomy ReservoirPudenz-Schulte Medical Research Corp.1988—
+1K063836Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters…Medtronic Neurosurgery2007—
+1K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
FIG. 1 — Lineage of K874498, 1988–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K063836Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701…Medtronic Neurosurgery20070
K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 12, 2009Not classifiedZ-1148-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1127-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1146-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1145-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1139-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1124-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1137-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1152-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1138-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1125-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1130-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1131-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1126-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1135-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1147-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1134-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1140-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1151-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1143-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1133-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1142-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1132-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1141-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1149-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1136-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1144-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1128-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1129-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
Feb 12, 2009Not classifiedZ-1150-2009Device DesignThe ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

The 5 latest of 29 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063836 (Medtronic Neurosurgery, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LKG devices

LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKG

FDA has decided no LKG device since 2007.

Median 510(k) review, days · LKG

Too few LKG 510(k)s in any year since 2007 to give a median.

Recalls per year · LKG

No recall names LKG since 2007.

Adverse event reports per year · LKG

14in 2025

2009: 12011: 22013: 12014: 12015: 32016: 12018: 72019: 42020: 32021: 82022: 62023: 102024: 32025: 14
2007high 14 (2025) · low 0 (2007)2025

MAUDE reports naming product code LKG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—02
20120—00
20130—01
20140—01
20150—03
20160—01
20170—00
20180—07
20190—04
20200—03
20210—08
20220—06
20230—010
20240—03
20250—014
20260—0—

More from Pudenz-Schulte Medical Research Corp.

40 FDA decisions under this applicant name. See the company

  • K960055Medtronic PS Medical Bioglide Vascular Catheter, SNGL Lumen Model Nos 8960 & 8932Pudenz-Schulte Medical Research Corp. · 1996
  • K954409PS Medical Ipi Vascular Access CatheterPudenz-Schulte Medical Research Corp. · 1995
  • K951258PS Medical Bioglide CSF-Flow Control Shunt KitPudenz-Schulte Medical Research Corp. · 199531 recalls
  • K934796Ipi Low Profile ImportPudenz-Schulte Medical Research Corp. · 1994
  • K934167Ipi Dual Lumen PortPudenz-Schulte Medical Research Corp. · 1994

Recent decisions in LKG

The LKG category page

  • K950315Cordis CSF ReservoirCordis Corp. · 1995
  • K881690Port-a-Cath Portal Introducer ForcepsPharmacia Deltec, Inc. · 1988
  • K881493Port-a-Cath Implantable Access System - Kit Conf.Pharmacia Deltec, Inc. · 1988
  • K874468P-S Medical Ventricular Access PortPudenz-Schulte Medical Research Corp. · 1988
  • K833822P-S Medical CSF Access Dev 15MM/25MMPudenz-Schulte Medical Research Corp. · 1984

https://510kreport.com/device/K874498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874498: CSF-Ventriculostomy Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874498

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026