Pioneer Viggo, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pioneer Viggo, Inc.” (first 1979, latest 1982), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| FPB | Filter, Infusion Line | 2 | 2 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Pioneer Viggo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823120 | EXACTA & CONNECTA STOPCOCKS W/EXTENSION | FMG | 1982-11-08 | 17 |
| K813454 | I.V. FILTER-PREVENT | FPB | 1982-01-05 | 26 |
| K812159 | INTRAVASCULAR CATHETER | FOZ | 1981-08-31 | 33 |
| K811171 | VASCULON II I.V. CATHETER | FOZ | 1981-05-27 | 29 |
| K801537 | START IT WITH & WITHOUT I.V. CATH. UNIT | FOZ | 1980-09-19 | 78 |
| K791809 | BLOOD TRANSFUSION MICROFILTER | FPB | 1979-10-26 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Pioneer Viggo, 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.
- Pioneer Surgical Technology (77 510(k)s)
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (9 510(k)s)
- Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (7 510(k)s)
- Pioneer Medical, Inc. (2 510(k)s)
- Pioneer Sundries Products , Ltd. (2 510(k)s)
- Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech (2 510(k)s)
- Pioneer Surgical Technology, Inc. (Rti Surgical, I (2 510(k)s)
- Pioneer Intl. Co. (1 510(k)s)
- Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) (1 510(k)s)
- Pioneer Trading Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pioneer Viggo, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Pioneer Viggo, Inc.” (first 1979, latest 1982), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pioneer Viggo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pioneer Viggo, Inc. is 31 days.
Which FDA product codes appear under Pioneer Viggo, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 3); FPB (Filter, Infusion Line, 2); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 6 Pioneer Viggo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Pioneer Viggo, 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.