O-Two Medical Technologies, Inc.
Brampton Ontario, CA
O-TWO MEDICAL TECHNOLOGIES, INC. appears in FDA device records in Brampton Ontario, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for O-Two Medical Technologies, Inc. between 2005 and 2018. The busiest year on record is 2005, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173205 | Equinox Advantage | BZR | Substantially Equivalent | |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | BTL | Substantially Equivalent | |
| K113687 | EQUINOX RELIEVE | BZR | Substantially Equivalent | |
| K112546 | O_TWO CPAP SYSTEM | BYE | Substantially Equivalent | |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | BTL | Substantially Equivalent | |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | BTL | Substantially Equivalent | |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | BTL | Substantially Equivalent | |
| K051889 | CAREVENT CA AND DRA | BTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610861 | 3002807836 | O-TWO MEDICAL TECHNOLOGIES, INC. | 45A Armthorpe Road, Brampton Ontario L6T 5M4 CA | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- CATCannula, Nasal, Oxygen
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- CAFNebulizer (Direct Patient Interface)
- DQAOximeter
- LZAPolymer Patient Examination Glove
- BTAPump, Portable, Aspiration (Manual Or Powered)
- CANRegulator, Pressure, Gas Cylinder
- JBSTimer, General Laboratory
- BYXTubing, Pressure And Accessories
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0978-2019 | e700 Automatic Transport Ventilator, Model Number 01EVE700 | 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 circuit. | Class I | Terminated | |
| Z-0977-2019 | e600 Automatic Transport Ventilator, Model Number 01EVE600 | 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 circuit. | Class I | Terminated | |
| Z-0976-2019 | 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 circuit. | Class I | Terminated | |
| Z-2885-2018 | O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | Higher levels of nitrous oxide delivered than specification | Class II | Terminated | |
| Z-2731-2017 | 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-adhering and are intended to be used on 1st and 2nd degree burns. | 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. . | Class II | Terminated | |
| Z-2705-2017 | 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 a rate appropriate for adult patients | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain