FDA product code MJF: Check Valve, Retrograde Flow (In-Line)
MJF is the FDA product code for check valve, retrograde flow (in-line). It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under MJF. The average 510(k) review took 111 days (median 111).
Classification
| Field | Value |
|---|---|
| Device name | Check Valve, Retrograde Flow (In-Line) |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MJF clearance
Top MJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icu Medical, Inc. | 1 | 1986-08-18 |
Most recent MJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K861586 | Icu Medical, Inc. | LOPEZ VALVE | 1986-08-18 | 111 |
Recalls for MJF devices
openFDA lists no recalls for product code MJF.
Frequently asked questions
What is FDA product code MJF?
MJF is the FDA product code for check valve, retrograde flow (in-line). It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is MJF?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJF?
Across 1 cleared submissions the average was 111 days from receipt to decision (median 111).
Which companies have the most MJF clearances?
Icu Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJF
- Run a recall and safety report across every MJF manufacturer
- Watch product code MJF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times