AEROECLIPSE II BREATH ACTUATED NEBULIZER— 510(k) K053605

Name: FDA 510(k) clearance K053605
Creator: U.S. Food and Drug Administration
Published: 2006-02-27

Substantially Equivalent

Trudell Medical Intl.

FDA 510(k) clearance K053605 for AEROECLIPSE II BREATH ACTUATED NEBULIZER, Substantially Equivalent on 2006-02-27. Applicant: Trudell Medical Intl.. Device class: 2.

Clearance details

Applicant: Trudell Medical Intl.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2005-12-27
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: London, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

More clearances from Trudell Medical Intl.

view all

K131881 — OMBRA TABLE TOP COMPRESSOR2013-10-24
K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE2013-05-16
K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)2013-03-11
K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)2012-07-11
K110136 — RESPICHAMBER VALVED HOLDING CHAMBER2011-04-18

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.