Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greiner Meditech, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
112 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992145 | ECOMED SCALP VEIN SET | Greiner Meditech, Inc. | 1999-10-14 | 112 | 1 |
| K992244 | GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1999-07-26 | 24 | 0 |
| K991843 | GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUB | Greiner Meditech, Inc. | 1999-06-25 | 28 | 0 |
| K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-12-28 | 53 | 2 |
| K982998 | GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-10-21 | 55 | 0 |
| K982999 | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE | Greiner Meditech, Inc. | 1998-10-16 | 50 | 0 |
| K981619 | VACUETTE MULTIPLE SAMPLE LUER ADAPTER | Greiner Meditech, Inc. | 1998-07-15 | 70 | 0 |
| K980768 | VACUETTE HOLDEX | Greiner Meditech, Inc. | 1998-04-09 | 41 | 3 |
| K974873 | VACUETTE (MULTI-USE HOLDER) | Greiner Meditech, Inc. | 1998-02-05 | 38 | 0 |
| K973620 | VACUETTE MULTI-SAMPLE NEEDLE | Greiner Meditech, Inc. | 1997-12-17 | 85 | 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