Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GZB — Predicate Candidate Screening
139 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
239 days90th percentile
139clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Na | Boston Scientific Neuromodulation | 2024-08-23 | 268 | 0 |
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022-06-10 | 29 | 0 |
| K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2021-03-25 | 111 | 0 |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8 | Boston Scientific Neuromodulation | 2020-11-09 | 90 | 0 |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020-07-15 | 30 | 0 |
| K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | 2019-11-07 | 157 | 0 |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | 2019-07-11 | 90 | 0 |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2019-03-29 | 182 | 0 |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019-03-22 | 140 | 1 |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly | Stimwave Technologies Incorporated | 2018-09-19 | 159 | 0 |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loadi | Stimwave Technologies Incorporated | 2017-11-03 | 63 | 0 |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Ki | Stimwave Technologies Incorporated | 2017-05-02 | 105 | 0 |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Ki | Stimwave Technologies Incorporated | 2016-12-16 | 136 | 0 |
| K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016-08-26 | 177 | 0 |
| K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/ | Anchor Innovation Medical (A.I.M.) | 2015-07-27 | 112 | 0 |
| K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015-06-05 | 95 | 0 |
| K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | Stimwave Technologies Incorporated | 2014-10-10 | 135 | 0 |
| K140272 | SWIFT-LOCK ANCHOR | St Jude Medical | 2014-05-02 | 88 | 0 |
| K130545 | MULTI LEAD TRIAL CABLE | St Jude Medical | 2013-06-18 | 109 | 0 |
| K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | St. Jude Medical Neuromodulation | 2013-01-18 | 87 | 2 |
| K113611 | RAPID PROGRAMMER | St Jude Medical | 2012-04-20 | 136 | 0 |
| K113805 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2012-02-23 | 62 | 0 |
| K113400 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-12-16 | 29 | 0 |
| K112214 | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, | St. Jude Medical Neuromodulation | 2011-11-17 | 107 | 0 |
| K112849 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-10-27 | 28 | 0 |
| K111462 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-09-08 | 105 | 0 |
| K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 | Medtronic, Inc. | 2010-10-26 | 54 | 0 |
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Advanced Neuromodulation Systems | 2009-12-23 | 140 | 1 |
| K091993 | RAPID PROGRAMMER, VERSION 3.3.0 | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | 2009-07-31 | 29 | 0 |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | Advanced Neuromodulation Systems | 2009-06-02 | 62 | 0 |
| K081208 | CINCH ANCHOR, MODEL 1194 | Advanced Neuromodulation Systems | 2008-07-18 | 80 | 0 |
| K072462 | WIDE SPACED QUATTRODE LEADS | Advanced Neuromodulation Systems | 2007-10-11 | 41 | 0 |
| K070847 | TRIAL CABLE, 3009 | Advanced Neuromodulation Systems | 2007-04-11 | 14 | 0 |
| K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | Advanced Neuromodulation Systems | 2006-12-12 | 63 | 0 |
| K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | Medtronic, Inc. | 2006-08-16 | 28 | 0 |
| K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | Advanced Neuromodulation Systems | 2005-12-15 | 24 | 0 |
| K052374 | RAPID PROGEAMMER 3.0 | Advanced Neuromodulation Systems | 2005-11-22 | 84 | 0 |
| K052418 | AXXESS BUTTERFLY ANCHOR | Advanced Neuromodulation Systems | 2005-09-26 | 24 | 0 |
| K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION | Medtronic Inc.,Neurological Division. | 2005-07-28 | 27 | 0 |
| K050922 | ANS SCS ACCESSORY KIT | Advanced Neuromodulation Systems | 2005-05-18 | 35 | 0 |
| K050633 | TRIAL CABLE RETENTION CLIP | Advanced Neuromodulation Systems | 2005-04-21 | 41 | 0 |
| K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | Medtronic Vascular | 2004-03-25 | 21 | 0 |
| K040609 | RAPID PROGRAMMER | Advanced Neuromodulation Systems | 2004-03-25 | 17 | 0 |
| K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM | Advanced Neuromodulation Systems | 2004-01-30 | 60 | 0 |
| K033429 | LAMITRODE SPINAL CORD STIMULATION LEADS | Advanced Neuromodulation Systems | 2003-12-04 | 37 | 0 |
| K033016 | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD M | Medtronic Neurological | 2003-10-30 | 34 | 0 |
| K032751 | MODIFICATION TO RENEW LEAD EXTENSION | Advanced Neuromodulation Systems | 2003-10-06 | 31 | 0 |
| K032349 | PLACER | Advanced Neuromodulation Systems | 2003-10-03 | 95 | 0 |
| K032034 | ANS AXXESS PERCUTANEOUS LEAD | Advanced Neuromodulation Systems | 2003-10-03 | 94 | 0 |
| K032561 | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PER | Medtronic Vascular | 2003-09-11 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda