Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038277270

FEI Number

3038277270

Entity Name

BYONYKS MEDICAL DEVICES INC

City/State/Country

Itasca, IL, US

Establishment Address

550 E Devon Ave Ste 140, Itasca, IL 60143, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Byonyks Medical Devices Inc (Owner Number: 10093651)

Owner / Operator Contact Address

550 E Devon Ave, Suite 140, Itasca, IL 60143, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243371

PMA Number

N/A

All Registered Proprietary Names

Byonyks Automated PD Set DS-1 Byonyks X-1 APD Cycler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2025-06-30
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2025-06-30

Official Correspondent

Eric Flachbart

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Byonyks Medical Devices Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-05	Fresenius Medical Care North America	2	Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

Similar Registrations

Registration Number	Establishment Name	Location
1058584	Sterigenics US LLC	Charlotte, NC, US
3003504604	Gambro UF Solutions LLC	Plymouth, MN, US
3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3032828299	VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED	Bangalore Karnataka, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038277270. Last updated year: 2026. Please use registration number 3038277270 when referencing this establishment in official correspondence.