Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific Neuromodulation · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
376 days90th percentile
9clearances 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 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulatio | Boston Scientific Neuromodulation | 2024-08-21 | 376 | 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 |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | 2019-07-11 | 90 | 0 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual | Boston Scientific Neuromodulation | 2019-03-29 | 98 | 1 |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019-03-22 | 140 | 1 |
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