Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526854

FEI Number

1526854

Entity Name

BIONIX, LLC

City/State/Country

Maumee, OH, US

Establishment Address

1670 Indianwood Circle, Maumee, OH 43537, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIONIX, LLC (Owner Number: 1526854)

Owner / Operator Contact Address

1670 Indian Wood Circle, --, Maumee, OH 43537, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DeClogger TruGuard Shotblocker Ear Irrigation Basin SecureVac Systems SecureFoam System Pelvis Belly System T-Form SecureVac Box Adaptor Cerumen Suction Device Lighted Microsuction System BIONIX DISPOSABLE NASAL SPECULUM After Swim BIONIX OTOCLEAR SAFE IRRIGATION TIP Cerumen Suction Device Safe Straw Safe Ear Curettes ClearLook Lighted Ear Curettes Lighted Ear Curettes Lighted Placement IGLOO WOUND IRRIGATOR SutureOut BIONIX OTOCLEAR SAFE IRRIGATION OtoClear Single-Use SprayWash Kit OtoClear Aquabot OtoClear SprayWash OtoClear Spray Wash OTC Lighted Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-05-02
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-04-11
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2012-02-03
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2010-11-11
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-05-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-09-29
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1997-01-10
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2009-09-04
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2000-06-13
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2012-04-10
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2009-06-30
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1997-01-10
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-01-07
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-04-17
LRD	Applicator, Ent Drug	Ear, Nose, Throat	Class 1	874.5220	2000-06-13
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-09-11

Official Correspondent

Joshua Ball

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIONIX, LLC

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526854. Last updated year: 2026. Please use registration number 1526854 when referencing this establishment in official correspondence.