Data / Medical devices / Canada / Trudell Medical International
Trudell Medical International: FDA-registered device maker in LONDON Ontario, Canada, 19 510(k) clearances
Trudell Medical International is registered with the FDA (registration 9612777) in LONDON Ontario, Canada. It lists 7 device types. The FDA files 19 510(k) clearances under its listings, the newest dated January 15, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9612777
- FEI number
- 3001610754
- Address
- 725 Baransway Drive, LONDON Ontario, Canada, N5V 5G4
- Owner or operator
- TRUDELL MEDICAL INTERNATIONAL (8020351)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 3, 2001
- Registered through
- 2026
- Brand names listed
- AeroChamber Plus Flow-Vu aVHC, AeroChamber Plus Z Stat aVHC, AeroChamber mini Aerosol Chamber, AeroChamber mini Holding Chamber, AeroChamber* MV Holding Chamber, AeroChamber2go Anti-Static Valved Holding Chamber, AeroEclipse II BAN Nebulizer, AeroEclipse XL BAN Nebulizer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Specification developer | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| January 15, 2025 | K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | NVP | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| August 24, 2023 | K220145 | Monaghan medical filtered mouthpiece kit | CAF | Substantially Equivalent | Monaghan Medical Corporation | accessdata.fda.gov |
| June 14, 2021 | K203400 | Corrugated tube with mouthpiece accessory | CAF | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| January 11, 2019 | K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | NVP | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| August 17, 2018 | K173918 | VersaPAP Positive Airway Pressure (PAP) Device | BWF | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| May 2, 2018 | K173825 | MC 300R* Nebulizer | CAF | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| February 28, 2018 | K173367 | MC 300* Nebulizer | CAF | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| October 15, 2015 | K150173 | Aerobika OPEP Devive with Manometer | BWF | Substantially Equivalent | Trudell Medical International | accessdata.fda.gov |
| August 15, 2014 | K140919 | RESPICONNECT ADAPTER | CAF | Substantially Equivalent | Trudell Medical Int'L | accessdata.fda.gov |
| October 24, 2013 | K131881 | OMBRA TABLE TOP COMPRESSOR | BTI | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| May 16, 2013 | K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | BWF | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| April 18, 2011 | K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| April 9, 2009 | K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | CAF | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| August 12, 2008 | K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | CAF | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| February 27, 2006 | K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | CAF | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| September 21, 2005 | K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| May 23, 2003 | K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | BZH | Substantially Equivalent | Monaghan Medical Corp. | accessdata.fda.gov |
| July 5, 2000 | K001137 | AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) | CAF | Substantially Equivalent | Trudell Medical Int'L | accessdata.fda.gov |
| April 10, 1991 | K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | CCQ | Substantially Equivalent | Monaghan Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Meter, Peak Flow, Spirometry
- All makers of Mask, Oxygen
- All makers of Compressor, Air, Portable
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated January 15, 2025. 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.