FIB · Class II · 21 CFR 876.5820

FDA Product Code FIB: Protector, Transducer, Dialysis

Leading manufacturers include Bain Medical Equipment (Guangzhou) Co., Ltd. and Cordis Corp..

35
Total
35
Cleared
102d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Protector, Transducer, Dialysis Devices (Product Code FIB)

35 devices
1–24 of 35
Cleared Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
K240164
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 158d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892
Cordis Corp.
Gastroenterology & Urology · 30d

About Product Code FIB - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code FIB since 1981, with 35 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.