Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stimlabs, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 | 83 | 0 |
| K242828 | Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC | 2024-10-18 | 29 | 0 |
| K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024-02-02 | 270 | 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