Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013517171

FEI Number

3013517171

Entity Name

KM Medical

City/State/Country

North York Ontario, CA

Establishment Address

640 Petrolia Rd, North York Ontario M3J 2W3, CA

Establishment Type(s)

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

Owner / Operator

KM Medical (Owner Number: 10054719)

Owner / Operator Contact Address

640 Petrolia Rd, North York, CA-ON M3J 2W3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tubes, vials, systems, serum separators, blood collection Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Conveen Contour; Conveen Security+ BD Single Sample Luer Adapter; BD Vacutainer Single Sample Luer A Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Tiemann Catheter Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada PULSE OXIMETER Masimo Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Syringe, piston ALLDRESS; Exufiber; LYOFOAM Dressings (A, C, T, Extra); LYOFOAM MAX; Melgisorb Plus; Mepilex; Mepilex Border; Mepilex Bo Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Catheter Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada BD Sharps Collectors TUBE, BLD COLL VAC Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada Medline Canada, Viscot, Becton dickinson Canada

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-05-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-02-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-03-24
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-09-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-02
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-04-23
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2022-01-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-07-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-03
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-06-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2023-08-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-07-31
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-02-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-02
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2020-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-04-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-07-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-05-13
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-01-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-12-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-02-18
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2021-03-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-02-22
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-09-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-05-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-01-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2017-10-31
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-07-27
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2023-05-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-06-18
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2025-06-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-03
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2024-01-03
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-03-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-02-11
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2025-05-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-02-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-02-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-09-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-09-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-09-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-02
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-08-02
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2018-07-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-10-31
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-07-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-04-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-02-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-12-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-07-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-09-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-06-04
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2023-01-16
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-04-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-12-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-12-10
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2021-01-29

Official Correspondent

Khalid Mahmoud

US Agent Details

Celia Parnicky Email: manager@airshiptrading.com Phone: (954) 2610657

Related Public Records

Same Entity

KM Medical

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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013517171. Last updated year: 2026. Please use registration number 3013517171 when referencing this establishment in official correspondence.