510(k) · Cleared

Cleared

Model 3587A Resume II Lead

K915540510(k) TraditionalCleared Jan 22, 199243-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 Jan 22, 1992 after a 43-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided: Jan 22, 1992
Review: 43 days
Class: Class II
Product code: GZF
Recalls: None
Predicates: 0

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

This deviceK915540 Model 3587A Resume II LeadMedtronic Vascular · 1992
Descendant · cites it directly · 14 of its ownK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
Descendant · 2 generations on · 13 of its ownK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
Descendant · 3 generations on · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
Descendant · 4 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
Descendant · 4 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2001high 3 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 15 · See all

K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 2001 · cites it directly14descendants
K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002 · 2 generations on13descendants
K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · 3 generations on12descendants
K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 4 generations on11descendants
K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 4 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K915540	Model 3587A Resume II Lead	Medtronic Vascular	1992	—
+1	K011702	Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx	Vertis Neuroscience, Inc.	2001	—
+2	K022241	Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG…	Vertis Neuroscience, Inc.	2002	—
+3	K061166	Deepwave Percutaneous Neuromodulation Pain Therapy System	Biowave Corporation	2006	—
+4	K072123	Homewave Neuromodulations Pain Therapy Device	Biowave Corporation	2008	—
+4	K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…	Spr Therapeutics, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2006	1	0
2008	1	0
2009	1	0
2016	1	0
2017	1	0
2018	1	0
2021	3	0
2022	2	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K915540, 1992–2025Source: 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? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K011702	Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx	Vertis Neuroscience, Inc.	2001	14

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, K011702 (Vertis Neuroscience, Inc., 2001) has gone furthest, with 14 descendants 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/K915540 · printed Nov 3, 2026

Cite this page

510(k) Report. “K915540: Model 3587A Resume II Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K915540

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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