510(k) · Cleared

Cleared

Models 3987 and 3988 Resume Lead for PNS

K920567510(k) TraditionalCleared May 20, 1992103-day reviewClass II21 CFR 882.5870

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

Medtronic Vascular · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Cleared on May 20, 1992 after a 103-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: May 20, 1992
Review: 103 days
Class: Class II
Product code: GZF
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK920567 Models 3987 and 3988 Resume Lead for PNSMedtronic Vascular · 1992
Descendant · cites it directly · 1 of its ownK032561 Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral…Medtronic Vascular · 2003
Descendant · 2 generations on · 0 of its ownK040568 Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004

Most influential descendants

Showing 2 of 2 · See all

K032561Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation…Medtronic Vascular · 2003 · cites it directly1descendant
K040568Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920567	Models 3987 and 3988 Resume Lead for PNS	Medtronic Vascular	1992	—
+1	K032561	Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve…	Medtronic Vascular	2003	—
+2	K040568	Polyether Urethane Material Change in Neurostimulation Leads	Medtronic Vascular	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K920567, 1992–2004Source: 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 GZF? 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 GZF device

#1 K243782 StimTrial Neuromodulation Systemscore 11.8 · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K032561	Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation…	Medtronic Vascular	2003	1

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, K032561 (Medtronic Vascular, 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GZF devices

GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZF

2in 2025

2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZF

99in 2019

2007high 99 (2019)2026

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

Recalls per year · GZF

No recall names GZF since 2007.

Adverse event reports per year · GZF

597in 2025

2007high 678 (2024) · low 7 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	7
2008	0	—	13
2009	0	—	10
2010	0	—	24
2011	0	—	17
2012	0	—	12
2013	0	—	77
2014	0	—	268
2015	1	—	346
2016	1	—	414
2017	1	—	330
2018	0	—	318
2019	3	99	64
2020	2	—	104
2021	1	—	226
2022	1	—	183
2023	1	—	524
2024	2	—	678
2025	2	—	597
2026	2	—	—

https://510kreport.com/device/K920567 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920567: Models 3987 and 3988 Resume Lead for PNS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920567

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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