Greiner Vacuette North America, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Greiner Vacuette North America, Inc.” (first 2000, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Review panels
Most recent Greiner Vacuette North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014104 | VACUETTE EDTA K2 TUBES | PJE | 2002-02-01 | 50 |
| K012043 | VACUETTE EDTA K2 GEL TUBES | PJE | 2001-09-24 | 87 |
| K011786 | VACUETTE SAFETY BLOOD COLLECTION SET | FMI | 2001-07-12 | 34 |
| K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER | FMI | 2001-04-30 | 140 |
| K002777 | VACUETTE WITH PPACK | JKA | 2000-10-05 | 29 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2005-07-28.
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 Bio-One Vacuette North America (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Greiner Vacuette North America, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Greiner Vacuette North America, Inc.” (first 2000, latest 2002), 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 Vacuette North America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Greiner Vacuette North America, Inc. is 50 days.
Which FDA product codes appear under Greiner Vacuette North America, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); PJE (Blood/Plasma Collection Device For Dna Testing, 2); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 5 Greiner Vacuette North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Greiner Vacuette 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.