Data / Medical devices / United States / Byonyks Medical Devices Inc
Byonyks Medical Devices Inc: FDA-registered device maker in Itasca, IL, United States, 1 510(k) clearance
Byonyks Medical Devices Inc is registered with the FDA (registration 3038277270) in Itasca, IL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038277270
- Address
- 550 E Devon Ave Ste 140, Itasca, IL, United States, 60143
- Owner or operator
- Byonyks Medical Devices Inc (10093651)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 30, 2025
- Registered through
- 2026
- Brand names listed
- Byonyks Automated PD Set DS-1, Byonyks X-1 APD Cycler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2025 | K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | FKX | Substantially Equivalent | Byonyks Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- All makers of System, Peritoneal, Automatic Delivery
Updated May 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.