Sensortek, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sensortek, Inc.” (first 1984, latest 1987), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| LLN | Device, Vibration Threshold Measurement | 1 | 1 |
| LQW | Test, Temperature Discrimination | 1 | 1 |
Review panels
- Anesthesiology (2)
- Neurology (2)
- General Hospital (1)
Most recent Sensortek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864345 | NTE-2 THERMAL SENSITIVITY TESTER | LQW | 1987-01-29 | 86 |
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | LLN | 1986-12-03 | 78 |
| K852228 | ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS | BZT | 1985-09-03 | 104 |
| K844056 | THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM | FLL | 1985-01-09 | 83 |
| K844055 | ESOPHAGEAL STETHO SCOPE | BZT | 1984-10-25 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Sensortek, 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 Sensortek, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sensortek, Inc.” (first 1984, latest 1987), across 4 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 Sensortek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sensortek, Inc. is 83 days.
Which FDA product codes appear under Sensortek, Inc.?
The most frequent FDA product codes under this applicant name are BZT (Stethoscope, Esophageal, With Electrical Conductors, 2); FLL (Continuous Measurement Thermometer, 1); LLN (Device, Vibration Threshold Measurement, 1).
Next steps
- See all 5 Sensortek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZT, Sensortek, 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.