510(k) · Cleared

Cleared

P-S Medical CSF Access Dev 15MM/25MM

K833822510(k) TraditionalCleared May 25, 1984205-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

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

Cleared on May 25, 1984 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: May 25, 1984
Review: 205 days
Class: Class II
Product code: LKG
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK833822 P-S Medical CSF Access Dev 15MM/25MMPudenz-Schulte Medical Research Corp. · 1984
Descendant · cites it directly · 0 of its ownK042198 PS Medical Neurosurgical ImplantsMedtronic Neurosurgery · 2004

Most influential descendants

Showing 1 of 1 · See all

K042198PS Medical Neurosurgical ImplantsMedtronic Neurosurgery · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K833822	P-S Medical CSF Access Dev 15MM/25MM	Pudenz-Schulte Medical Research Corp.	1984	—
+1	K042198	PS Medical Neurosurgical Implants	Medtronic Neurosurgery	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K833822, 1984–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042198	PS Medical Neurosurgical Implants	Medtronic Neurosurgery	2004	0

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?

Of its descendants, K042198 (Medtronic Neurosurgery, 2004) 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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
2010	—	0
2011	—	2
2012	—	0
2013	—	1
2014	—	1
2015	—	3
2016	—	1
2017	—	0
2018	—	7
2019	—	4
2020	—	3
2021	—	8
2022	—	6
2023	—	10
2024	—	3
2025	—	14
2026	—	—

https://510kreport.com/device/K833822 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833822: P-S Medical CSF Access Dev 15MM/25MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833822

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Record history

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