DeviceClearance

Product code CAF— Anesthesiology

NEBULIZER HEATER

Classification name
Nebulizer (Direct Patient Interface)
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Total cleared
508
First cleared
Most recent

Market context for product code CAF

FDA has cleared 508 devices under product code CAF between 1976 and 2026, filed by 252 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CAF

Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

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

Recent clearances under product code CAF

1–100 of 508

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