Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Next Science, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
304 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203446 | TorrentX Wound Wash | Next Science, LLC | 2021-09-23 | 304 | 0 |
| K203835 | MIS Solution | Next Science, LLC | 2021-04-23 | 114 | 0 |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020-01-23 | 147 | 0 |
| K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017-03-06 | 112 | 0 |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016-09-07 | 135 | 0 |
| K150792 | Next Science Wound Gel | Next Science, LLC | 2015-12-17 | 267 | 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