Pro-Tec Containers, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pro-Tec Containers, Inc.” (first 1989, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 47 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 | 5 | 5 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Review panels
Most recent Pro-Tec Containers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945276 | PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G | FMI | 1994-12-14 | 47 |
| K945275 | PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1 | FMI | 1994-12-14 | 47 |
| K945274 | PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 | FMI | 1994-12-14 | 47 |
| K945273 | PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2 | FMI | 1994-12-14 | 47 |
| K942179 | PRO-TEC DISPOSABLE SHARPS CONTAINERS | FMI | 1994-12-02 | 212 |
| K892665 | PRO-JECT(TM) SAFETY NEEDLE HOLDER | JKA | 1989-10-04 | 174 |
Recalls
openFDA lists no recalls under a recalling firm named Pro-Tec Containers, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pro-Tec Containers, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Pro-Tec Containers, Inc.” (first 1989, latest 1994), 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 Pro-Tec Containers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pro-Tec Containers, Inc. is 47 days.
Which FDA product codes appear under Pro-Tec Containers, 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, 1).
Next steps
- See all 6 Pro-Tec Containers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Pro-Tec Containers, 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.