510(k) Report

510(k) · Cleared

Cleared

Rapid Programmer, Version 3.3.0

K091993510(k) SpecialCleared Jul 31, 200929-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

Advanced Neuromodulation Systems, Inc. (Ans Inc.) · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Jul 31, 2009 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jul 31, 2009
Review
29 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K091993Source: FDA 510(k) database · 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), the FDA 510(k) statement (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. #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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by…

Read the full statement (108 words)

The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS)

in the treatment of chronic pain of trunk and limbs, either as the sole mitigating

agent, or as an adjunct to other modes of therapy used in a multidisciplinary

approach.

The Rapid Programmer is intended to assist clinicians in determining the

optimum performance while automatically logging procedures data. Rapid

Programmer also allows the clinician to optimize performance by leading the

patient through a series of device parameter combinations and recording the

stimulation effects. This system uses a touch screen computer to program the

stimulator to the required waveforms and electrode configurations and to log the

information derived.

Indications for use as stated in the FDA 510(k) statement.

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/K091993 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091993: Rapid Programmer, Version 3.3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091993

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026