Next Science, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Next Science, LLC” (first 2015, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 141 days. Since 2017 the median was 130 days, against 227 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 267 |
| 2016 | 1 | 135 |
| 2017 | 1 | 112 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 147 |
| 2021 | 2 | 209 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Next Science, LLC took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 227 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 4 | 4 |
| FQH | Lavage, Jet | 2 | 2 |
Review panels
Most recent Next Science, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203446 | TorrentX Wound Wash | FRO | 2021-09-23 | 304 |
| K203835 | MIS Solution | FRO | 2021-04-23 | 114 |
| K192349 | Bactisure Wound Lavage | FQH | 2020-01-23 | 147 |
| K163188 | Next Science Wound Gel (Rx) | FRO | 2017-03-06 | 112 |
| K161165 | Next Science Irrigation Solution | FQH | 2016-09-07 | 135 |
| K150792 | Next Science Wound Gel | FRO | 2015-12-17 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Next Science, LLC.
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.
- Next Orthosurgical (6 510(k)s)
- Next Mobility, LLC (2 510(k)s)
- Next Wave, Inc. (2 510(k)s)
- Next Millennium Software Solutions, Inc. (1 510(k)s)
- Next Sight Srl (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Next Science, LLC?
FDA lists 6 510(k) clearances under the applicant name “Next Science, LLC” (first 2015, latest 2021), across 2 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 Next Science, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Next Science, LLC is 141 days. Since 2017: 130 days, versus 227 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Next Science, LLC?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 4); FQH (Lavage, Jet, 2).
Next steps
- See all 6 Next Science, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRO, Next Science, LLC'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.