Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001124136

FEI Number

3001124136

Entity Name

INNOPEX LIMITED

City/State/Country

Toronto Ontario, CA

Establishment Address

240 Bartor Rd Units 9&10, Toronto Ontario M9M2W6, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Innopex Limited (Owner Number: 10047406)

Owner / Operator Contact Address

140 Cidermill Ave, Concord, CA-ON L4K4k5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220137

PMA Number

N/A

All Registered Proprietary Names

Blood Collection set OPHTHALMOSCOPE MULTIPLE Needle Injection Dispossable Blood collection tubes Absorbabale Sutures Multiple Guiding Catheter Syringe Piston SUCTION DRAINAGE KIT blood collection unit multiple ostomy pouch IV Administration Set Multiple Umbilical clamp surgical cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-06-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-05-28
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-05-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-05-28
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-05-13
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2017-11-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2026-02-24
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-29
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2018-12-27
GXB	Esthesiometer	Neurology	Class 1	882.1500	2026-06-04
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-02-25
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-02-25
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2018-12-27
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2018-12-27
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2020-03-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-16
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-12-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-12-12
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2021-06-27
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2026-06-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-06-05
JES	Floss, Dental	Dental	Class 1	872.6390	2024-03-21
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2026-04-28
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2026-06-10
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-04-01
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2026-06-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-05-28
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2026-06-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-11
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2026-06-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-14
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-05-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-04
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-02-03
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2022-02-03
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-03-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-02-21
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2026-05-13
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2026-05-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-05-03
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-01-02
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-11-05
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2026-06-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2026-03-26
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-02-06
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-06-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-05
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2026-06-04
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2017-05-09
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2021-03-16
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2020-03-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-09-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-07-06
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-05-28
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2019-06-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-03-21
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-05-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-02-26
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2026-06-04
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2018-12-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2015-12-15
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2017-05-09
JES	Floss, Dental	Dental	Class 1	872.6390	2023-07-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-03-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-13
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-05-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-05-13
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2023-11-30
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2023-11-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-12-27
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2025-03-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-08-25
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-03-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-05-28
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-05-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-12-26
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2022-07-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-05-28
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-06-07
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2026-06-04
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2026-06-16
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-06-01
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2025-03-24
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2026-06-16
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2026-05-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-04-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-02-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-30
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2019-08-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-05-03

Official Correspondent

Joel Menzelefsky

US Agent Details

abe Teitelbaum Email: abe@bntrading.net Phone: (973) 9233003

Related Public Records

Same Entity

Innopex Limited

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

View Entity Profile →

Related 510(k) Records

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K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
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Related Recall Records

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Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001124136. Last updated year: 2026. Please use registration number 3001124136 when referencing this establishment in official correspondence.