Greiner America, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Greiner America, Inc.” (first 1996, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 | 1 |
Review panels
Most recent Greiner America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971220 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | 1997-06-04 | 63 |
| K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | 1997-05-12 | 40 |
| K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | 1997-05-12 | 40 |
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | GIM | 1997-05-02 | 30 |
| K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | JKA | 1996-09-05 | 188 |
| K960858 | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR | JKA | 1996-08-30 | 182 |
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | JKA | 1996-08-30 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Greiner America, 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 Meditech, Inc. (10 510(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 America, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Greiner America, Inc.” (first 1996, latest 1997), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Greiner America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner America, Inc. is 63 days.
Which FDA product codes appear under Greiner America, Inc.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 6); GIM (Tubes, Vacuum Sample, With Anticoagulant, 1).
Next steps
- See all 7 Greiner America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Greiner America, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.