Greiner Bio-One Na, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Greiner Bio-One Na, Inc.” (first 2016, latest 2019), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 129 days. Since 2017 the median was 109 days, against 183 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 251 |
| 2017 | 1 | 89 |
| 2018 | 2 | 105 |
| 2019 | 1 | 176 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Greiner Bio-One Na, Inc. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
Review panels
- General Hospital (3)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Greiner Bio-One Na, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182078 | MiniCollect K2E K2EDTA Tubes | JKA | 2019-01-25 | 176 |
| K180545 | VACUETTE SAFELINK Holder with male luer lock | FMI | 2018-05-21 | 81 |
| K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | FMI | 2018-04-19 | 129 |
| K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | JSM | 2017-03-06 | 89 |
| K160532 | Greiner Holdex | FMI | 2016-11-03 | 251 |
Recalls
openFDA lists no recalls under a recalling firm named Greiner Bio-One Na, 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 America, Inc. (7 510(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 Bio-One Na, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Greiner Bio-One Na, Inc.” (first 2016, latest 2019), across 3 product codes in 3 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 Bio-One Na, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner Bio-One Na, Inc. is 129 days. Since 2017: 109 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Greiner Bio-One Na, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 3); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1); JSM (Culture Media, Non-Propagating Transport, 1).
Next steps
- See all 5 Greiner Bio-One Na, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Greiner Bio-One Na, 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.