Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GZF · Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
175 daysmedian FDA review time
339 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025-07-16 | 219 | 0 |
| K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025-07-03 | 218 | 0 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulatio | Boston Scientific Neuromodulation | 2024-08-21 | 376 | 0 |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | 2024-06-20 | 267 | 0 |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | 2023-04-11 | 341 | 0 |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022-02-23 | 244 | 0 |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | 2021-08-27 | 339 | 0 |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External T | Micron Medical Corporation | 2020-08-14 | 136 | 0 |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | 2020-03-27 | 29 | 0 |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | 2019-10-31 | 295 | 0 |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single | Nalu Medical, Inc. | 2019-09-06 | 99 | 0 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual | Boston Scientific Neuromodulation | 2019-03-29 | 98 | 1 |
| K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Ki | Stimwave Technologies Inc., Dba Stimq, LLC | 2017-08-04 | 87 | 6 |
| K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | Stimq, LLC | 2016-03-11 | 220 | 6 |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter | Bioness, Inc. | 2015-02-20 | 175 | 0 |
| K000852 | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | 2001-01-19 | 310 | 0 |
| K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3 | Medtronic Vascular | 2000-04-12 | 89 | 0 |
| K982902 | PERIPHERAL NERVE STIMULATION | Medtronic Vascular | 1998-11-10 | 88 | 0 |
| K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | Medtronic Vascular | 1996-05-21 | 97 | 0 |
| K950425 | TECOTHANE 55D | Medtronic Vascular | 1995-04-19 | 76 | 0 |
| K925952 | MEDTRONIC MODEL 3990 PNS LEAD | Medtronic Vascular | 1993-08-20 | 269 | 0 |
| K920567 | MODELS 3987 AND 3988 RESUME LEAD FOR PNS | Medtronic Vascular | 1992-05-20 | 103 | 0 |
| K915540 | MODEL 3587A RESUME II LEAD | Medtronic Vascular | 1992-01-22 | 43 | 0 |
| K904409 | MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER | Medtronic Vascular | 1991-01-30 | 126 | 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