Industrial & Biomedical Sensors Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Industrial & Biomedical Sensors Corp.” (first 1980, latest 1980), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Industrial & Biomedical Sensors Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802218 | SD-900 OSCILLOMETRIC BP MONITOR | DXN | 1980-10-23 | 41 |
| K802202 | SD-800 BLOOD PRESSURE MONITOR | DXN | 1980-10-23 | 42 |
| K802201 | SD-700 BLOOD PRESSURE MONITOR | DXN | 1980-10-23 | 42 |
| K802204 | CT-1600 DIGITAL PULSE RATE MONITOR | DRT | 1980-10-03 | 22 |
| K802203 | CM-700A AUTO-INFLATE CONTROL MODULE | DXN | 1980-10-03 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Industrial & Biomedical Sensors 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.
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.
- Industrial Clothings, Ltd. (14 510(k)s)
- Industrial & Medical Design, Inc. (3 510(k)s)
- Industrial Water Solutions, Inc. (2 510(k)s)
- Industrial Accelerator Co. (1 510(k)s)
- Industrial Chemical Measurement (1 510(k)s)
- Industrial Clothings (Pvt), Ltd. (1 510(k)s)
- Industrial Energy Specialists, Inc. (1 510(k)s)
- Industrial Technology Research Institute (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Industrial & Biomedical Sensors Corp.?
FDA lists 5 510(k) clearances under the applicant name “Industrial & Biomedical Sensors Corp.” (first 1980, latest 1980), across 2 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 Industrial & Biomedical Sensors Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Industrial & Biomedical Sensors Corp. is 41 days.
Which FDA product codes appear under Industrial & Biomedical Sensors Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 5 Industrial & Biomedical Sensors Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Industrial & Biomedical Sensors 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.