Data / Medical devices / Canada / O-Two Medical Technologies, Inc.
O-Two Medical Technologies, Inc.: FDA-registered device maker in Brampton Ontario, Canada, 21 510(k) clearances
O-Two Medical Technologies, Inc. is registered with the FDA (registration 9610861) in Brampton Ontario, Canada. It lists 21 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 29, 2018. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610861
- FEI number
- 3002807836
- Address
- 45A Armthorpe Road, Brampton Ontario, Canada, L6T 5M4
- Owner or operator
- O-TWO MEDICAL TECHNOLOGIES, INC. (8020332)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 21, 1980
- Registered through
- 2026
- Brand names listed
- AEROSOL MASK, CANNULA NASAL, CANNULA NASAL w/TUBING, CAREvent ATV+ & CAREvent MRI, CAREvent BLS, BLS+, ALS, ALS+, ATV, CAREvent CA & CAREvent DRA, CAREvent EMT, CAREvent Handheld CPAP System 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 |
|---|---|---|---|---|---|---|
| August 29, 2018 | K173205 | Equinox Advantage | BZR | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| June 21, 2018 | K170886 | HOMED Mesh Nebulizer | CAF | Substantially Equivalent | Shenzhen Homed Medical Device Co., Ltd. | accessdata.fda.gov |
| March 16, 2015 | K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | BTL | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| April 17, 2013 | K121770 | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER | CAF | Substantially Equivalent | Headstar Medical Products Co., Ltd. | accessdata.fda.gov |
| April 30, 2012 | K113687 | EQUINOX RELIEVE | BZR | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| December 27, 2011 | K112546 | O_TWO CPAP SYSTEM | BYE | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| November 18, 2010 | K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | CAP | Substantially Equivalent | A Plus Medical | accessdata.fda.gov |
| May 6, 2010 | K093862 | CAREVENT HANDHELD CPAP SYSTEM | BTL | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| March 6, 2009 | K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | BTL | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| August 13, 2007 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| September 28, 2005 | K051469 | CAREVENT ATV+ AND CAREVENT MRI | BTL | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| August 30, 2005 | K051889 | CAREVENT CA AND DRA | BTL | Substantially Equivalent | O-Two Medical Technologies, Inc. | accessdata.fda.gov |
| July 8, 2004 | K040841 | POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| June 26, 2003 | K021328 | SMART BAG MO | BTM | Substantially Equivalent | O-Two Systems International, Inc. | accessdata.fda.gov |
| June 6, 2001 | K002846 | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR | BTM | Substantially Equivalent | Headstar Medical Products Co., Ltd. | accessdata.fda.gov |
| April 22, 1999 | K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | BTL | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| October 29, 1998 | K983705 | EMT RESUSCITATOR | BTL | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| January 7, 1997 | K960995 | CPR BIO-BARRIER FACESHEILD | CBP | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| October 14, 1994 | K940927 | RESCUE BREATHER | CBP | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| October 25, 1993 | K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH | BTL | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| January 22, 1993 | K922810 | ODYSSEY | BTM | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 12, 2019 | 82178 | Class I | Terminated | e500 Automatic Transport Ventilator, Model Number 01EVE500 | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short | accessdata.fda.gov |
| May 14, 2018 | 80414 | Class II | Terminated | O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | Higher levels of nitrous oxide delivered than specification | accessdata.fda.gov |
| September 30, 2015 | 77534 | Class II | Terminated | Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non | For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief products to prevent potential contamination.. | accessdata.fda.gov |
| June 23, 2015 | 77528 | Class II | Terminated | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at | Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label. | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Mask, Gas, Anesthetic
- All makers of Valve, Non-Rebreathing
Updated April 4, 2019. 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.