# Trudell Medical International

- Location (FDA's records): London, CA
- FDA decisions: 9 (2015–2025): 9 510(k) clearances
- Product codes: CAF (4), BWF (3), NVP (2)
- 510(k) review time since 2016: median 186 days, against 219 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Trudell Medical Intl.: 4 (https://510kreport.com/company/trudell-medical-intl)
- Warren C. Miller: 1 (https://510kreport.com/company/warren-c-miller)
- Dhd Healthcare Corp.: 1 (https://510kreport.com/company/dhd-healthcare)

## Firms that cite its devices most
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K173367: MC 300* Nebulizer (2018), cited by 2
- K150173: Aerobika OPEP Devive with Manometer (2015), cited by 1
- K173918: VersaPAP Positive Airway Pressure (PAP) Device (2018), cited by 1
- K181649: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (2019), cited by 1

## Recent decisions
- K242667: AeroChamber2go Anti-Static Valved Holding Chamber (Jan 15, 2025)
- K203400: Corrugated tube with mouthpiece accessory (Jun 14, 2021)
- K200063: AeroEclipse* ONE BAN (Jul 17, 2020)
- K183108: Combined Aerobika OPEP and VersaPAP device (Aug 16, 2019)
- K181649: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (Jan 11, 2019)
- K173918: VersaPAP Positive Airway Pressure (PAP) Device (Aug 17, 2018)
- K173825: MC 300R* Nebulizer (May 2, 2018)
- K173367: MC 300* Nebulizer (Feb 28, 2018)

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