Biosensor Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biosensor Corp.” (first 1983, latest 1999), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
Review panels
- Cardiovascular (9)
- Radiology (1)
Most recent Biosensor Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990956 | BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 | DQK | 1999-06-14 | 84 |
| K974546 | BIOSENSOR HOLTER MONITOR SYSTEM | DQK | 1998-03-04 | 90 |
| K974192 | BIOSENSOR HOLTER MONITOR SYSTEM | DQK | 1998-03-04 | 117 |
| K950944 | AMBULATORY (HOLTER) RECORDING SYSTEM | DQK | 1996-06-18 | 487 |
| K960449 | PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) | DPS | 1996-05-30 | 121 |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | JAF | 1996-04-12 | 640 |
| K950723 | AMBULATORY (HOLTER) RECORDING SYSTEM | DQK | 1996-02-09 | 358 |
| K922027 | AMBULATORY (HOLTER) RECORDING, MODIFICATION | DSI | 1993-02-17 | 328 |
| K895266 | AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED | DSI | 1990-01-26 | 156 |
| K831676 | BIOSENSOR ASC SYSTEM | DSI | 1983-12-01 | 192 |
Recalls
openFDA lists no recalls under a recalling firm named Biosensor 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 Biosensor Corp.?
FDA lists 10 510(k) clearances under the applicant name “Biosensor Corp.” (first 1983, latest 1999), 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 Biosensor Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosensor Corp. is 174 days.
Which FDA product codes appear under Biosensor Corp.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 5); DSI (Detector And Alarm, Arrhythmia, 3); DPS (Electrocardiograph, 1).
Next steps
- See all 10 Biosensor Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Biosensor 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.