# Trudell Medical Intl.

- Location (FDA's records): London, CA
- FDA decisions: 12 (2002–2013): 12 510(k) clearances
- Product codes: CAF (5), NVP (4), BWF (2), BTI (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 15 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dhd Healthcare Corp.: 1 (https://510kreport.com/company/dhd-healthcare)
- Healthscan Products, Inc.: 1 (https://510kreport.com/company/healthscan-products)
- Aerogen (Ireland), Ltd.: 1 (https://510kreport.com/company/aerogen-ireland)
- Vega Technologies, Inc.: 1 (https://510kreport.com/company/vega-technologies)
- Pari Respiratory Equipment, Inc.: 1 (https://510kreport.com/company/pari-respiratory-equipment)

## Firms that cite its devices most
- Trudell Medical International: 4 (https://510kreport.com/company/trudell-medical-international)
- Respironics New Jersey, Inc.: 3 (https://510kreport.com/company/respironics-new-jersey)
- Pharmacaribe: 1 (https://510kreport.com/company/pharmacaribe)
- Enchant Tek Co., Ltd.: 1 (https://510kreport.com/company/enchant-tek)
- Monaghan Medical Corp.: 1 (https://510kreport.com/company/monaghan-medical)
- Aga Plastic Ind. Com. Ltda.: 1 (https://510kreport.com/company/aga-plastic-ind-com)
- Activaero America, Inc.: 1 (https://510kreport.com/company/activaero-america)
- Koo (Shanghai) Industries Co., Ltd.: 1 (https://510kreport.com/company/koo-shanghai-industries)

## Its most-cited devices
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator (2007), cited by 5
- K052332: Aerochamber Z-Stat Plus Valved Holding Chamber (2005), cited by 3
- K053605: Aeroeclipse II Breath Actuated Nebulizer (2006), cited by 2
- K080926: Aeroeclipse Durable Breath Actuated Nebulizer (2008), cited by 2
- K112010: Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC) (2012), cited by 1
- K032972: Aerochamber Max Valved Holding Chamber (2004), cited by 1

## Recent decisions
- K131881: Ombra Table Top Compressor (Oct 24, 2013)
- K123400: Aerobika  Positive Expiratory Pressure Device (May 16, 2013)
- K123614: Solarys Ventilator Aerosol Delivery System (as) (Mar 11, 2013)
- K112010: Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC) (Jul 11, 2012)
- K110136: Respichamber Valved Holding Chamber (Apr 18, 2011)
- K090065: Aerochamber Mini Ventilation Chamber (Apr 9, 2009)
- K080926: Aeroeclipse Durable Breath Actuated Nebulizer (Aug 12, 2008)
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator (Apr 11, 2007)

Source page: https://510kreport.com/company/trudell-medical-intl