FPD · Class II · 21 CFR 876.5980

FDA Product Code FPD: Tube, Feeding

Leading manufacturers include Vygon USA.

59
Total
59
Cleared
167d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 51d recently vs 169d historically

FDA 510(k) Cleared Tube, Feeding Devices (Product Code FPD)

59 devices
1–24 of 59
Cleared Dec 19, 2024
Nutrifit
K243361
Vygon USA
Gastroenterology & Urology · 51d

About Product Code FPD - Regulatory Context

510(k) Submission Activity

59 total 510(k) submissions under product code FPD since 1976, with 59 receiving FDA clearance (average review time: 167 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under FPD have taken an average of 51 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.

FPD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →