Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seedling Enterprises., LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012033 | MULTIFUNCTION ENDOSCOPIC INSTRUMENT | Seedling Enterprises., LLC | 2001-09-20 | 83 | 0 |
| K010710 | SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REU | Seedling Enterprises., LLC | 2001-05-18 | 70 | 0 |
| K002841 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | 2000-12-08 | 87 | 0 |
| K001723 | COOL-TEC ELECTRODES | Seedling Enterprises., LLC | 2000-07-19 | 43 | 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