Data / Medical devices / Canada / KM Medical
KM Medical: FDA-registered device maker in North York Ontario, Canada, 67 510(k) clearances
KM Medical is registered with the FDA (registration 3013517171) in North York Ontario, Canada. It lists 57 device types. The FDA files 67 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013517171
- Address
- 640 Petrolia Rd, North York Ontario, Canada, M3J 2W3
- Owner or operator
- KM Medical (10054719)
- Roles
- Exporter to the US
- First device listed
- April 18, 2017
- Registered through
- 2027
- Brand names listed
- ALLDRESS; Exufiber; LYOFOAM Dressings (A, C, T, Extra); LYOFOAM MAX; Melgisorb Plus; Mepilex; Mepilex Border; Mepilex Bo, BD 1ml Insulin Syringe U-100 Luer-Lok Tip; BD 1mL Luer-Lok Hypodermic Syringe; BD 1mL Luer-Lok Hypodermic Syringe wit, BD Blood Collection Set; BD Safety Lok Blood Collection Set, BD Sharps Collectors, BD Single Sample Luer Adapter; BD Vacutainer Single Sample Luer A, CATHETER, COUDE, Catheter, Conveen Contour; Conveen Security+ and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 10, 2026 | K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 23, 2026 | K251864 | Rubber Utility Catheter | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 2, 2024 | K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 3, 2023 | K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | JOW | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 28, 2019 | K180739 | Clearlink System Solution Set | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| December 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 4, 2014 | K141719 | BIOGEL PL MICRO SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 8, 2013 | K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 1, 2013 | K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 23, 2012 | K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP | GEI | Substantially Equivalent | Olsen Medical | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| December 8, 2011 | K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | FPB | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 9, 2010 | K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| November 18, 2009 | K090915 | STERILE WATER FOR INHALATION FLEX BAG, USP | BTT | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| August 25, 2009 | K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | JKA | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| August 26, 2008 | K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| June 24, 2008 | K081160 | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| December 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 11, 2007 | K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| April 10, 2006 | K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 7, 2006 | K053442 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| February 1, 2006 | K053443 | BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 16, 2005 | K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| May 14, 2004 | K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| February 4, 2004 | K033719 | BARD TIGERTAIL URETERAL CATHETER | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| May 6, 2003 | K030580 | SURETEMP PLUS | FLL | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| May 8, 2002 | K020203 | PADPRO MODEL #2516 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| February 1, 2002 | K013971 | BD VACUTAINER SAFETY COAGULATION TUBE | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| August 14, 2000 | K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | Ssl Americas, Inc. (Regent Medical) | accessdata.fda.gov |
| November 17, 1999 | K993120 | MODIFIED BLOOD RECIPIENT SET | BRZ | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 28, 1999 | K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| August 17, 1998 | K981792 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 17, 1998 | K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | JKA | Substantially Equivalent for Some Indications | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| March 3, 1998 | K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 24, 1998 | K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | PJE | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 29, 1997 | K971514 | REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE | LYY | Substantially Equivalent | London International Group, Inc. | accessdata.fda.gov |
| March 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 23, 1996 | K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 9, 1996 | K960264 | CONMED EKG STRIPPER | DRX | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| November 28, 1995 | K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 31, 1995 | K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| November 10, 1994 | K944566 | VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 7, 1994 | K943141 | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| July 11, 1994 | K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING | KGN | Substantially Equivalent for Some Indications | Brennen Medical, Inc. | accessdata.fda.gov |
| July 10, 1992 | K921520 | VACUTAINER BRAND LUER ADAPTER | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 29, 1992 | K921806 | VACUTAINER(R) BRAND SST(R) AND CAT TUBES | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 16, 1991 | K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | EZC | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| August 9, 1990 | K901449 | VACUTAINER PLUS WITH HEMOGARD CLOSURE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 18, 1990 | K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | DRX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 6, 1985 | K853146 | RESPIR THER HUMID CONTAIN STERILE WATER FOR USP | BTT | Substantially Equivalent | Automatic Liquid Packaging, Inc. | accessdata.fda.gov |
| April 25, 1984 | K833491 | ENDO BITE BLOCK | KTI | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| April 4, 1979 | K790366 | URINE CULTURE KIT | JTW | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated April 10, 2026. 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.