Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Greiner Vacuette North America, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
140 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014104 | VACUETTE EDTA K2 TUBES | Greiner Vacuette North America, Inc. | 2002-02-01 | 50 | 0 |
| K012043 | VACUETTE EDTA K2 GEL TUBES | Greiner Vacuette North America, Inc. | 2001-09-24 | 87 | 0 |
| K011786 | VACUETTE SAFETY BLOOD COLLECTION SET | Greiner Vacuette North America, Inc. | 2001-07-12 | 34 | 2 |
| K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER | Greiner Vacuette North America, Inc. | 2001-04-30 | 140 | 0 |
| K002777 | VACUETTE WITH PPACK | Greiner Vacuette North America, Inc. | 2000-10-05 | 29 | 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