Greiner Bio-One Vacuette North America: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Greiner Bio-One Vacuette North America” (first 2001, latest 2008), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 1 | 1 |
Review panels
Most recent Greiner Bio-One Vacuette North America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080235 | SAFETY INFUSION SET | FMI | 2008-04-24 | 85 |
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | PJE | 2005-04-15 | 175 |
| K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | 2003-12-29 | 56 |
| K023971 | VACUETTE TRACE ELEMENTS TUBES | JKA | 2003-01-27 | 59 |
| K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | JKA | 2001-06-28 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Greiner Bio-One Vacuette North America.
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 Na, Inc. (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 Vacuette North America?
FDA lists 5 510(k) clearances under the applicant name “Greiner Bio-One Vacuette North America” (first 2001, latest 2008), 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 Bio-One Vacuette North America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner Bio-One Vacuette North America is 59 days.
Which FDA product codes appear under Greiner Bio-One Vacuette North America?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 2); PJE (Blood/Plasma Collection Device For Dna Testing, 1).
Next steps
- See all 5 Greiner Bio-One Vacuette North America clearances with predicates and recalls
- Run predicate analysis for product code FMI, Greiner Bio-One Vacuette North America'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.