V-Tech, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “V-Tech, Inc.” (first 1982, latest 1991), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (11)
- Clinical Toxicology (9)
- Microbiology (1)
- Pathology (1)
Most recent V-Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914303 | TARGET(TM)-HOG | JHI | 1991-10-11 | 16 |
| K910893 | TARGET(TM) CANNABINOIDS-R TEST | LDJ | 1991-04-03 | 30 |
| K910892 | TARGET(TM) CANNABINOIDS-V TEST | LDJ | 1991-04-03 | 30 |
| K910739 | TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) | DKZ | 1991-03-21 | 28 |
| K910738 | TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) | DKZ | 1991-03-19 | 26 |
| K910123 | TARGET COCAINE METABOLITE-V | KLN | 1991-03-19 | 67 |
| K910122 | TARGET COCAINE METABOLITE-R | KLN | 1991-03-19 | 67 |
| K903937 | TARGET(TM) HOG ONE STEP | JHI | 1990-10-22 | 56 |
| K890978 | TARGET OPIATES-R | DJG | 1989-11-17 | 263 |
| K890979 | TARGET OPIATES-V | DJG | 1989-10-04 | 219 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named V-Tech, 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 V-Tech, Inc.?
FDA lists 22 510(k) clearances under the applicant name “V-Tech, Inc.” (first 1982, latest 1991), across 15 product codes in 4 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 V-Tech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name V-Tech, Inc. is 43 days.
Which FDA product codes appear under V-Tech, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 4); DJG (Enzyme Immunoassay, Opiates, 2); DKZ (Enzyme Immunoassay, Amphetamine, 2).
Next steps
- See all 22 V-Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, V-Tech, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.