Data / Medical devices / United States / Monaghan Medical Corp.
Monaghan Medical Corp.: FDA-registered device maker in Plattsburgh, NY, United States, 17 510(k) clearances
Monaghan Medical Corp. is registered with the FDA (registration 1317346) in Plattsburgh, NY, United States. It lists 9 device types. The FDA files 17 510(k) clearances under its listings, the newest dated January 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1317346
- Address
- 153 Industrial Blvd., Plattsburgh, NY, United States, 12901
- Owner or operator
- MONAGHAN MEDICAL CORP. (1317346)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- November 13, 2007
- Registered through
- 2026
- Brand names listed
- AE Mask, AEROBIKA® OPEP, AEROCHAMBER, AEROCHAMBER PLUS ZSTAT AVHC, AEROGEAR ASTHMA ACTION KIT, AEROVENT PLUS CHC, AeroChamber2go, Aerochamber Mini Holding Chamber and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Device, Rebreathing | BYW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Nebulizer, Electrically Powered | JPW | 1 | Manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer, Repackager or relabeler | 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 |
| 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 |
| February 28, 2018 | K173367 | MC 300* Nebulizer | CAF | Substantially Equivalent | Trudell Medical International | 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 17, 2013 | K123945 | STRIVE DUAL ZONE PEAK FLOW METER | BZH | Substantially Equivalent | Monaghan Medical Corp. | accessdata.fda.gov |
| July 11, 2012 | K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | NVP | Substantially Equivalent | Trudell Medical Intl. | accessdata.fda.gov |
| June 9, 2011 | K110273 | AEROVENT PLUS CHC | CAF | Substantially Equivalent | Monaghan Medical Corporation | accessdata.fda.gov |
| April 9, 2009 | K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | 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 |
| January 24, 1994 | K930574 | AEROCHAMBER W/MASK, MODIFIED | CAF | Substantially Equivalent | Monaghan Medical Corp. | 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 Meter, Peak Flow, Spirometry
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Pump, Nebulizer, Electrically Powered
- All makers of Holding Chambers, Direct Patient Interface
- All makers of Device, Rebreathing
- All makers of Compressor, Air, Portable
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.