Irex Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Irex Corp.” (first 1977, latest 1985), across 9 product codes in 3 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (4)
- Radiology (4)
- Clinical Chemistry (1)
Most recent Irex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844404 | IREX PS, PORTABLE SCANNER AND 118 | IYO | 1985-02-04 | 83 |
| K843643 | COLOR DOPPLER 880 | DXK | 1985-01-31 | 136 |
| K842408 | IREX 730 MECHANICAL SECTOR SCANNER | JAF | 1984-11-29 | 163 |
| K840139 | IREX 720 SECTOR SCANNER | IYO | 1984-05-09 | 126 |
| K827370 | IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM | — | 1982-06-28 | 77 |
| K813544 | IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. | IYN | 1982-02-05 | 46 |
| K811246 | DOPPLER ULTRASOUND BLOOD FLOWMETER | DPW | 1981-08-12 | 99 |
| K792525 | IREX CARDIOPLAN | DQK | 1979-12-27 | 21 |
| K791317 | IREX REAL TIME PHASED ARRAY SYSTEM | CDP | 1979-09-17 | 67 |
| K771372 | SYSTEM II | DSF | 1977-08-04 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Irex 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 Irex Corp.?
FDA lists 10 510(k) clearances under the applicant name “Irex Corp.” (first 1977, latest 1985), across 9 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 Irex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irex Corp. is 80 days.
Which FDA product codes appear under Irex Corp.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1); DPW (Flowmeter, Blood, Cardiovascular, 1).
Next steps
- See all 10 Irex Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Irex 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.