Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greiner America, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
188 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971220 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-06-04 | 63 | 0 |
| K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-12 | 40 | 1 |
| K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-12 | 40 | 1 |
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-02 | 30 | 5 |
| K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | Greiner America, Inc. | 1996-09-05 | 188 | 1 |
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & G | Greiner America, Inc. | 1996-08-30 | 182 | 3 |
| K960858 | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GE | Greiner America, Inc. | 1996-08-30 | 182 | 2 |
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