Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merchsource, 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) |
|---|---|---|---|---|---|
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | 2025-10-30 | 164 | 0 |
| K252093 | Light Therapy Mask (1019055) | Merchsource, LLC | 2025-10-16 | 105 | 0 |
| K252096 | Light Therapy Decollete Mask (1019135) | Merchsource, LLC | 2025-10-01 | 90 | 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