510(k) · Cleared

Cleared

Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads or TTL

K964172510(k) TraditionalCleared Jul 3, 1997258-day reviewClass II21 CFR 882.5880

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

Medtronic Vascular · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Jul 3, 1997 as substantially equivalent to K913993 (Medtronic Vascular, 1992) and 5 other predicates after a 258-day review. Its family tree reaches back 1 generation to 1989.

Decided: Jul 3, 1997
Review: 258 days
Class: Class II
Product code: GZB
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K884948 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK884948 Model 3587A Resume Epidural LeadMedtronic Vascular · 1989
This deviceK964172 Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse…Medtronic Vascular · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884948	Model 3587A Resume Epidural Lead	Medtronic Vascular	1989	—
0 (this device)	K964172	Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads…	Medtronic Vascular	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	2	0
1993	1	0
1995	1	0

FIG. 1 — Lineage of K964172, 1989–1997Source: 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 GZB? 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 GZB device

#1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 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? (6)

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
*	K913993	Medtronic Models 3982 a,B,C&D Stag Array Res Leads Summary page 1 …Modetl 3487A leads. » Medtronic considers the Mode! 3991a series of spinal cord stimulation leads to be substantially equivalent to the current Model 3882 Symmix lead K3913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3…	Medtronic Vascular	1992	—
*	K952459	Medtronic Model 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C Leads or, Transverse… Summary page 1 …series of spinal cord stimulation leads to be substantially equivalent to the current Model 3882 Symmix lead K3913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the le…	Medtronic Vascular	1995	—
*	K923931	Medtronic Model 3487A Pisces-Quad Lead Summary page 1 …lent to the current Model 3882 Symmix lead K3913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available s…	Medtronic Vascular	1993	—
*	K910199	Medtronic Model 3487A Pisces-Quad Lead Summary page 1 …ent Model 3882 Symmix lead K3913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available spinal cord stimu…	Medtronic Vascular	1991	—
*	K923567	Medtronic Model 3888 Pisces-Quad Plus Lead Summary page 1 …3882 Symmix lead K3913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available spinal cord stimulation le…	Medtronic Vascular	1992	—
*	K884948	Model 3587A Resume Epidural Lead Summary page 1 …13993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available spinal cord stimulation leads. There are three…	Medtronic Vascular	1989	—

Also cleared against K913993: 1 other device →

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?

None of the 6 ancestors has a recall.
1 other device also cites its predicate K913993.

How does its category compare?

All GZB devices

GZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZB

1in 2024

2007high 4 (2011) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZB

149in 2019

2007high 149 (2019) · low 62 (2009)2026

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

Recalls per year · GZB

1in 2010

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZB

313in 2025

2007high 10,849 (2014) · low 59 (2009)2025

MAUDE reports naming product code GZB, 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	2	—	0	201
2008	1	—	1	68
2009	3	62	0	59
2010	1	—	1	157
2011	4	67	0	471
2012	2	—	0	1,090
2013	2	—	0	4,428
2014	2	—	0	10,849
2015	2	—	0	7,507
2016	2	—	0	4,556
2017	2	—	0	5,511
2018	1	—	0	5,244
2019	4	149	0	643
2020	2	—	0	466
2021	1	—	0	332
2022	1	—	0	209
2023	0	—	0	236
2024	1	—	0	318
2025	0	—	0	313
2026	0	—	1	—

What is it indicated for?

Model 3991 A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.

All other uses are considered investigational.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964172 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964172: Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads or TTL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964172

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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