Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Neuromodulation Systems — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
107 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Advanced Neuromodulation Systems | 2009-12-23 | 140 | 1 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K030461 | A127 LEAD EXTENSION | Advanced Neuromodulation Systems | 2003-04-24 | 71 | 0 |
| K030674 | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD | Advanced Neuromodulation Systems | 2003-03-28 | 24 | 0 |
| K030118 | RAPID PROGRAMMAR | Advanced Neuromodulation Systems | 2003-03-11 | 57 | 0 |
| K021518 | PAINDOC | Advanced Neuromodulation Systems | 2002-06-06 | 27 | 0 |
| K000852 | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | 2001-01-19 | 310 | 0 |
| K992946 | RENEW RECEIVER | Advanced Neuromodulation Systems | 1999-09-24 | 23 | 0 |
| K991784 | RENEW LEAD EXTENSION | Advanced Neuromodulation Systems | 1999-06-24 | 30 | 0 |
| K990469 | LAMITRODE LEADS | Advanced Neuromodulation Systems | 1999-06-03 | 107 | 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