I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM— 510(k) K102454

Substantially Equivalent

Respironics Respiratory Drug Delivery (Uk) , Ltd.

FDA 510(k) clearance K102454 for I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM, Substantially Equivalent on 2011-10-25. Applicant: Respironics Respiratory Drug Delivery (Uk) , Ltd..

Clearance details

Applicant: Respironics Respiratory Drug Delivery (Uk) , Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2010-08-27
Decision date: 2011-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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.