Monaghan Medical Corp.
Plattsburgh, NY, US
MONAGHAN MEDICAL CORP. appears in FDA device records in Plattsburgh, NY. FDA records list 35 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 35 510(k) clearances for Monaghan Medical Corp. between 1976 and 2023. The busiest year on record is 1982, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1982 | 5 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 4 |
| 1993 | 1 |
| 1994 | 2 |
| 1996 | 4 |
| 1997 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| 2011 | 1 |
| 2013 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220145 | Monaghan medical filtered mouthpiece kit | CAF | Substantially Equivalent | |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | BZH | Substantially Equivalent | |
| K110273 | AEROVENT PLUS CHC | CAF | Substantially Equivalent | |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | BZH | Substantially Equivalent | |
| K023097 | TRUEZONE PEAK FLOW METER | BZH | Substantially Equivalent | |
| K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | CAF | Substantially Equivalent | |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | BZH | Substantially Equivalent | |
| K964130 | AEROGEAR ASTHMA ACTION KIT | BZH | Substantially Equivalent | |
| K963089 | TRUZONE PEAK FLOW METER | BZH | Substantially Equivalent | |
| K963095 | TRUPEAK PEAK FLOW METER | BZH | Substantially Equivalent | |
| K955234 | TRUPEAK PEAK FLOW METER | BZH | Substantially Equivalent | |
| K955262 | TRUZONE PEAK FLOW METER | BZH | Substantially Equivalent | |
| K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE | BYP | Substantially Equivalent | |
| K930574 | AEROCHAMBER W/MASK, MODIFIED | CAF | Substantially Equivalent | |
| K926307 | PEAK FLOW METER | BZH | Substantially Equivalent | |
| K911263 | 22MM ID/OD ADAPTER | CAI | Substantially Equivalent | |
| K900576 | MODIFIED AEROCHAMBER WITH MASK | CCQ | Substantially Equivalent | |
| K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | CCQ | Substantially Equivalent | |
| K910138 | TVS II ELECTRONIC INCENTIVE SPIROMETER | BWF | Substantially Equivalent | |
| K884389 | MODIFIED 225/SIMV VOLUME VENTILATOR | CBK | Substantially Equivalent | |
| K894969 | AEROVENT | BZA | Substantially Equivalent | |
| K884942 | MONAGHAN RVM, MODEL 761 | BZK | Substantially Equivalent | |
| K884803 | AEROCHAMBER M.V. | CAF | Substantially Equivalent | |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | CCQ | Substantially Equivalent | |
| K872037 | AEROCHAMBER | BYP | Substantially Equivalent | |
| K863612 | MONAGHAN RVM, MODEL 760 AND 761 | BZQ | Substantially Equivalent | |
| K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 | BZQ | Substantially Equivalent | |
| K834228 | LITHOTRIPTOR ELECTRODE 4.5F | FFK | Substantially Equivalent | |
| K830086 | 4.5 F LITHOTRIPTOR ELECTRODE | FFK | Substantially Equivalent | |
| K822635 | 225 S.I.M.V. VENTILATOR | CBK | Substantially Equivalent | |
| K822437 | MONAGHAN AEROCHAMBER | BYP | Substantially Equivalent | |
| K822585 | LITHOTRIPTOR ELECTRODE 4.5F | FFK | Substantially Equivalent | |
| K821649 | MONAGHAN'S PRESSURE ALARM | CAP | Substantially Equivalent | |
| K820606 | MONAGHAN'S TRUE VOLUME EXERCISER | BWF | Substantially Equivalent | |
| K760352 | CIRCUIT, INTENSIVE CARE VENTILATOR | CAZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1317346 | 1317346 | MONAGHAN MEDICAL CORP. | 153 Industrial Blvd., Plattsburgh, NY 12901 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BTICompressor, Air, Portable
- BZAConnector, Airway (Extension)
- BYWDevice, Rebreathing
- NVPHolding Chambers, Direct Patient Interface
- FFKLithotriptor, Electro-Hydraulic
- BYFMask, Oxygen, Low Concentration, Venturi
- BZHMeter, Peak Flow, Spirometry
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- JPWPump, Nebulizer, Electrically Powered
- BZKSpirometer, Monitoring (W/Wo Alarm)
- BWFSpirometer, Therapeutic (Incentive)
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain