AeroEclipse* ONE BAN— 510(k) K200063

Name: FDA 510(k) clearance K200063
Creator: U.S. Food and Drug Administration
Published: 2020-07-17

Substantially Equivalent

Trudell Medical International

FDA 510(k) clearance K200063 for AeroEclipse* ONE BAN, Substantially Equivalent on 2020-07-17. Applicant: Trudell Medical International. Device class: 2.

Clearance details

Applicant: Trudell Medical International
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2020-01-13
Decision date: 2020-07-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
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 International

view all

K242667 — AeroChamber2go Anti-Static Valved Holding Chamber2025-01-15
K203400 — Corrugated tube with mouthpiece accessory2021-06-14
K183108 — Combined Aerobika OPEP and VersaPAP device2019-08-16
K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)2019-01-11
K173918 — VersaPAP Positive Airway Pressure (PAP) Device2018-08-17

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.