Greiner Bio-One North America, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Greiner Bio-One North America, Inc.” (first 2006, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 | 2 | 54 |
| 2013 | 1 | 128 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 214 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Greiner Bio-One North America, Inc. took a median 214 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 5 | 5 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 5 | 5 |
Review panels
Most recent Greiner Bio-One North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | JKA | 2024-07-19 | 214 |
| K122687 | BLOOD CULTURE HOLDER | JKA | 2013-01-10 | 128 |
| K121908 | SAFETY INFUSION SET | FMI | 2012-07-25 | 26 |
| K113505 | VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER | FMI | 2012-02-17 | 81 |
| K103041 | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR | JKA | 2010-11-09 | 26 |
| K102774 | VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER | FMI | 2010-10-15 | 21 |
| K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR | JKA | 2008-12-16 | 162 |
| K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | FMI | 2007-09-14 | 25 |
| K063357 | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES | JKA | 2007-07-10 | 245 |
| K061483 | VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES | FMI | 2006-08-14 | 76 |
Recalls
25 product recalls in 25 recall events; 6 initiated in the last five years. Most recent: 2025-08-19.
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 Meditech, 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 Bio-One North America, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Greiner Bio-One North America, Inc.” (first 2006, latest 2024), across 2 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 Bio-One North America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner Bio-One North America, Inc. is 78 days.
Which FDA product codes appear under Greiner Bio-One North America, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 5); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 5).
Next steps
- See all 10 Greiner Bio-One North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Greiner Bio-One North 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, 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.