Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harvest Technologies, Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
171 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | Harvest Technologies, Corp. | 2012-09-21 | 171 | 1 |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYS | Harvest Technologies, Corp. | 2010-12-06 | 21 | 0 |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Harvest Technologies, Corp. | 2006-01-04 | 78 | 0 |
| K043261 | HARVEST GRAFT DELIVERY SYRINGE | Harvest Technologies, Corp. | 2005-03-11 | 107 | 1 |
| K020252 | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 | Harvest Technologies, Corp. | 2002-04-05 | 71 | 0 |
| K011032 | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/ | Harvest Technologies, Corp. | 2001-07-03 | 89 | 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