American Viggo: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “American Viggo” (first 1976, latest 1977), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | 4 | 4 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
Review panels
Most recent American Viggo 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771339 | MALE LUER LOCK PLUG | FPA | 1977-08-02 | 14 |
| K770528 | NEEDLE, MEMBRANE | FMI | 1977-04-29 | 42 |
| K770181 | I.V. CATHETER PLACEMENT UNIT | FOZ | 1977-03-30 | 62 |
| K770174 | LUER-LOCK EXTENSION SET | FPK | 1977-03-30 | 63 |
| K770154 | 3-WAY STOPCOCK WITH LUER-LOCK FITTING | KGZ | 1977-02-28 | 35 |
| K770096 | EPIDURAL BLOCK PROCEDURE PACK | CAZ | 1977-02-25 | 39 |
| K760679 | 4-WAY STOPCOCK W/7CM TUBING, | FMG | 1976-12-02 | 73 |
| K760678 | 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK | FMG | 1976-12-02 | 73 |
| K760667 | 4-WAY STOPCOCK W/10 CM EXTEN. TUBING | FMG | 1976-12-02 | 76 |
| K760666 | 4-WAY STOPCOCK W/LUER-LOCK FITTING | FMG | 1976-12-02 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named American Viggo.
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Viggo?
FDA lists 10 510(k) clearances under the applicant name “American Viggo” (first 1976, latest 1977), across 7 product codes in 3 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 American Viggo?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Viggo is 62 days.
Which FDA product codes appear under American Viggo?
The most frequent FDA product codes under this applicant name are FMG (Stopcock, I.V. Set, 4); CAZ (Anesthesia Conduction Kit, 1); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 10 American Viggo clearances with predicates and recalls
- Run predicate analysis for product code FMG, American Viggo'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.