Greiner Meditech, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Greiner Meditech, Inc.” (first 1997, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 52 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 6 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
Most recent Greiner Meditech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992145 | ECOMED SCALP VEIN SET | FPA | 1999-10-14 | 112 |
| K992244 | GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE | JKA | 1999-07-26 | 24 |
| K991843 | GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE | JKA | 1999-06-25 | 28 |
| K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | 1998-12-28 | 53 |
| K982998 | GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE | JKA | 1998-10-21 | 55 |
| K982999 | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE | JKA | 1998-10-16 | 50 |
| K981619 | VACUETTE MULTIPLE SAMPLE LUER ADAPTER | FMI | 1998-07-15 | 70 |
| K980768 | VACUETTE HOLDEX | FMI | 1998-04-09 | 41 |
| K974873 | VACUETTE (MULTI-USE HOLDER) | JKA | 1998-02-05 | 38 |
| K973620 | VACUETTE MULTI-SAMPLE NEEDLE | FMI | 1997-12-17 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Greiner Meditech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Greiner Bio-One North America, Inc. (10 510(k)s)
- Greiner America, Inc. (7 510(k)s)
- Greiner Bio-One Na, Inc. (5 510(k)s)
- Greiner Bio-One Vacuette North America (5 510(k)s)
- Greiner Vacuette North America, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Greiner Meditech, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Greiner Meditech, Inc.” (first 1997, latest 1999), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Greiner Meditech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner Meditech, Inc. is 52 days.
Which FDA product codes appear under Greiner Meditech, Inc.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 6); FMI (Needle, Hypodermic, Single Lumen, 3); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 10 Greiner Meditech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Greiner Meditech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.