QFJ · Class II · 21 CFR 870.1345

FDA Product Code QFJ: Intravascular Bleed Monitor

An Intravascular Bleed Monitor Is A Probe, Catheter, Or Catheter Introducer That Measures Changes In Bioimpedance And Uses An Algorithm To Detect Or Monitor Progression Of Potential Internal Bleeding Complications.

Leading manufacturers include Saranas, Inc..

2
Total
1
Cleared
213d
Avg days
2019
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Intravascular Bleed Monitor Devices (Product Code QFJ)

2 devices
1–2 of 2
Cleared May 25, 2023
Saranas Early Bird Bleed Monitoring System
K230273
Saranas, Inc.
Cardiovascular · 114d
Not Cleared Mar 01, 2019
Early Bird Bleed Monitoring System
DEN180021
Saranas, Inc.
Cardiovascular · 312d

About Product Code QFJ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QFJ since 2019, with 1 receiving FDA clearance (average review time: 213 days).

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