Sen Tech Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sen Tech Medical Corp.” (first 1984, latest 1991), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 1 | 1 |
Review panels
Most recent Sen Tech Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | GET | 1991-03-22 | 72 |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | CDS | 1986-03-14 | 84 |
| K854260 | CHEMPRO 1000 | CGA | 1985-11-19 | 27 |
| K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS | CEM | 1985-07-09 | 112 |
| K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. | CEM | 1984-07-06 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Sen Tech Medical Corp..
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 Sen Tech Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Sen Tech Medical Corp.” (first 1984, latest 1991), across 4 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 Sen Tech Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sen Tech Medical Corp. is 80 days.
Which FDA product codes appear under Sen Tech Medical Corp.?
The most frequent FDA product codes under this applicant name are CEM (Electrode, Ion Specific, Potassium, 2); CDS (Electrode, Ion Specific, Urea Nitrogen, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 5 Sen Tech Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CEM, Sen Tech Medical Corp.'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.