Product Code: MJF FDA class 2 21 CFR 880.5440

Check Valve, Retrograde Flow (In-Line)

General Hospital

The In-Line Retrograde Flow Check Valve is a one-directional flow control component used in medical fluid administration sets or infusion lines to prevent backflow of fluids toward the patient or the fluid source, maintaining the intended direction of flow during intravenous therapy or other fluid delivery procedures. Classified as a Class 2 device under 21 CFR 880.5440 within the General Hospital specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active

Research product code MJF in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
MJF
Device Class
FDA class 2
Regulation Number
880.5440
Medical Specialty
General Hospital
Review Panel
HO
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K861586 LOPEZ VALVE

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.