510(k) Report

510(k) · Cleared

Cleared

8-Channel Multiprog Implant Spinal Cord Stimulator

K860158510(k) TraditionalCleared Mar 7, 198650-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

Neuromed, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Mar 7, 1986 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 7, 1986
Review
50 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 3 descendants cleared1990200020102020
  1. This deviceK860158 8-Channel Multiprog Implant Spinal Cord StimulatorNeuromed, Inc. · 1986
  2. Descendant · cites it directly · 3 of its ownK960728 One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK991784 Renew Lead ExtensionAdvanced Neuromodulation Systems · 1999
  4. Descendant · 3 generations on · 0 of its ownK992946 Renew ReceiverAdvanced Neuromodulation Systems · 1999
  5. Descendant · 2 generations on · 0 of its ownK990469 Lamitrode LeadsAdvanced Neuromodulation Systems · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996 · cites it directly3descendants
  • K991784Renew Lead ExtensionAdvanced Neuromodulation Systems · 1999 · 2 generations on1descendant
  • K992946Renew ReceiverAdvanced Neuromodulation Systems · 1999 · 3 generations on0descendants
  • K990469Lamitrode LeadsAdvanced Neuromodulation Systems · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K8601588-Channel Multiprog Implant Spinal Cord StimulatorNeuromed, Inc.1986—
+1K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc.1996—
+2K991784Renew Lead ExtensionAdvanced Neuromodulation Systems1999—
+3K992946Renew ReceiverAdvanced Neuromodulation Systems1999—
+2K990469Lamitrode LeadsAdvanced Neuromodulation Systems1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199930
FIG. 1 — Lineage of K860158, 1986–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc.19963

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, K960728 (Neuromed, Inc., 1996) has gone furthest, with 3 descendants of its own.

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

2007: 22008: 12009: 32010: 12011: 42012: 22013: 22014: 22015: 22016: 22017: 22018: 12019: 42020: 22021: 12022: 12024: 1
2007high 4 (2011) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZB

149in 2019

2009: 62 days median2011: 67 days median2019: 149 days median
2007high 149 (2019) · low 62 (2009)2026

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

Recalls per year · GZB

1in 2010

2008: 12010: 12026 (partial year): 1
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

2007: 2012008: 682009: 592010: 1572011: 4712012: 1,0902013: 4,4282014: 10,8492015: 7,5072016: 4,5562017: 5,5112018: 5,2442019: 6432020: 4662021: 3322022: 2092023: 2362024: 3182025: 313
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0201
20081—168
2009362059
20101—1157
20114670471
20122—01,090
20132—04,428
20142—010,849
20152—07,507
20162—04,556
20172—05,511
20181—05,244
201941490643
20202—0466
20211—0332
20221—0209
20230—0236
20241—0318
20250—0313
20260—1—

More from Neuromed, Inc.

15 FDA decisions under this applicant name. See the company

  • K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996
  • K930536Neuromed Octrode Model MNR-88A-B-C Neurostim RecNeuromed, Inc. · 1994
  • K930498Neuromed Octrode Model MNT-98 Neurostimulator TranNeuromed, Inc. · 1994
  • K930242Introde Int-8Neuromed, Inc. · 1994
  • K921319Neuromed Model Oca-30 Octode and Model Sca-30Neuromed, Inc. · 1993

Recent decisions in GZB

The GZB category page

  • K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve…Boston Scientific Neuromodulation · 20241 recall
  • K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
  • K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
  • K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em…Boston Scientific Neuromodulation · 2020
  • K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020

https://510kreport.com/device/K860158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K860158: 8-Channel Multiprog Implant Spinal Cord Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860158

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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