Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harvest Technologies, 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) |
|---|---|---|---|---|---|
| K000456 | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HAR | Harvest Technologies, LLC | 2000-06-01 | 111 | 0 |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | Harvest Technologies, LLC | 1999-05-28 | 32 | 0 |
| K983022 | SMARTCELL PROCESSING SYSTEM | Harvest Technologies, LLC | 1999-04-02 | 214 | 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