DeviceClearance

Product code FXX— General, Plastic Surgery

Surgical Face Mask

Classification name
Mask, Surgical
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
607
First cleared
Most recent

Market context for product code FXX

FDA has cleared 607 devices under product code FXX between 1976 and 2026, filed by 466 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 FXX

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

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 FXX

1–100 of 607

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