Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greiner Bio-One Na, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
251 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | 2019-01-25 | 176 | 0 |
| K180545 | VACUETTE SAFELINK Holder with male luer lock | Greiner Bio-One Na, Inc. | 2018-05-21 | 81 | 1 |
| K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | 2018-04-19 | 129 | 0 |
| K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | 2017-03-06 | 89 | 0 |
| K160532 | Greiner Holdex | Greiner Bio-One Na, Inc. | 2016-11-03 | 251 | 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