Boston Scientific Neuromodulation: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Boston Scientific Neuromodulation” (first 2019, latest 2025), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 102 days. Since 2017 the median was 102 days, against 157 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 3 | 98 |
| 2020 | 2 | 60 |
| 2021 | 1 | 111 |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 2 | 322 |
| 2025 | 1 | 106 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Boston Scientific Neuromodulation took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 7 | 7 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 2 | 2 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | 1 | 0 |
Review panels
- Neurology (10)
- Orthopedic (1)
Most recent Boston Scientific Neuromodulation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | GXD | 2025-08-07 | 106 |
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZB | 2024-08-23 | 268 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZF | 2024-08-21 | 376 |
| K221376 | Nalu Neurostimulation System | GZB | 2022-06-10 | 29 |
| K203547 | Nalu Neurostimulation System | GZB | 2021-03-25 | 111 |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | GZB | 2020-11-09 | 90 |
| K201618 | Nalu Neurostimulation SCS system | GZB | 2020-07-15 | 30 |
| K190960 | Nalu Lead Blank (50cm) | GZB | 2019-07-11 | 90 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | GZF | 2019-03-29 | 98 |
| K183047 | Nalu Neurostimulation System | GZB | 2019-03-22 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140004 | PMA | SUPERION INTERSPINOUS SPACER | 2015-05-20 |
Recalls
25 product recalls in 14 recall events; 12 initiated in the last five years. Most recent: 2026-06-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Scientific Neuromodulation?
FDA lists 10 510(k) clearances under the applicant name “Boston Scientific Neuromodulation” (first 2019, latest 2025), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Boston Scientific Neuromodulation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Scientific Neuromodulation is 102 days. Since 2017: 102 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Boston Scientific Neuromodulation?
The most frequent FDA product codes under this applicant name are GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 7); GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief), 2); GXD (Generator, Lesion, Radiofrequency, 1).
Next steps
- See all 10 Boston Scientific Neuromodulation clearances with predicates and recalls
- Run predicate analysis for product code GZB, Boston Scientific Neuromodulation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.