Data / Medical devices / United States / Biomedix Wai

Biomedix Wai: FDA-registered device maker in Chanhassen, MN, United States, 2 510(k) clearances

Name: Biomedix Wai FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biomedix Wai is registered with the FDA (registration 1833470) in Chanhassen, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 29, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1833470
FEI number: 1000115518
Address: 8600 Shelby Court, Chanhassen, MN, United States, 55317
Owner or operator: WAI Medical Technologies LLC (10052511)
Roles: Complaint file establishment, Specification developer
First device listed: August 9, 2016
Registered through: 2026
Brand names listed: MedSource I.V. Administration Set, Select 3 IV admin set

Devices it lists

Device	Product code	Class	Role	Source
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Complaint file establishment	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
August 29, 2014	K142097	SELEC-3 I.V.ADMINISTRATION SET	FPA	Substantially Equivalent	Biomedix, Inc.	accessdata.fda.gov
April 22, 2014	K140442	MEDSOURCE SELECTABLE IV SET	LHI	Substantially Equivalent	Medsource International, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 14, 2014	69249	Class II	Terminated	Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE	Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.	accessdata.fda.gov

Compare with other makers

Updated October 6, 2014. 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.