FDA product code MJJ: Cpb Check Valve, Retrograde Flow, In-Line
MJJ is the FDA product code for cpb check valve, retrograde flow, in-line. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel. FDA has cleared 9 510(k) submissions under MJJ, from 8 different applicants. The average 510(k) review took 192 days (median 148). FDA has posted 36 recalls for MJJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cpb Check Valve, Retrograde Flow, In-Line |
| Device class | Class II |
| Regulation | 21 CFR 870.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MJJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 60 |
Compare with all 510(k) review times · Search every MJJ clearance
Top MJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Omni Medical, Inc. | 2 | 1993-03-08 |
| Quest Medical, Inc. | 1 | 2018-11-06 |
| Terumo Cardiovascular Systems Corporation | 1 | 2015-01-29 |
| 3t Medical Systems, LLC | 1 | 2001-08-15 |
| International Biophysics Corp. | 1 | 2000-01-14 |
3 more applicants have MJJ clearances. See the full list in Caduvo.
Most recent MJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182442 | Quest Medical, Inc. | MiniGuard Arterial Safety Valve | 2018-11-06 | 60 |
| K142500 | Terumo Cardiovascular Systems Corporation | One Way Soft Valve | 2015-01-29 | 146 |
| K001245 | 3t Medical Systems, LLC | 3T L. V. CONTROL VALVE | 2001-08-15 | 484 |
| K992785 | International Biophysics Corp. | IBC FLOGUARD, MODEL 6050 | 2000-01-14 | 148 |
| K982406 | Cobe Cardiovascular, Inc. | COBE VACUUM RELIEF CHECK VALVE | 1998-10-07 | 89 |
Recalls for MJJ devices
36 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-08-11.
Frequently asked questions
What is FDA product code MJJ?
MJJ is the FDA product code for cpb check valve, retrograde flow, in-line. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel.
What device class is MJJ?
Class II, regulation 21 CFR 870.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJJ?
Across 9 cleared submissions the average was 192 days from receipt to decision (median 148).
Which companies have the most MJJ clearances?
American Omni Medical, Inc. (2); Quest Medical, Inc. (1); Terumo Cardiovascular Systems Corporation (1); 3t Medical Systems, LLC (1); International Biophysics Corp. (1).
Have MJJ devices been recalled?
Yes: 36 product recalls across 2 recall events; the most recent began 2011-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MJJ
- Run a recall and safety report across every MJJ manufacturer
- Watch product code MJJ 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.
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