FDA product code MMP: Cover, Barrier, Protective
MMP is the FDA product code for cover, barrier, protective. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 15 510(k) submissions under MMP, from 14 different applicants. The average 510(k) review took 193 days (median 105). FDA has posted 30 recalls for MMP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cover, Barrier, Protective |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MMP clearance
Top MMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrapped IN Comfort | 2 | 2005-05-25 |
| Mtp Medical Technical Promotion GmbH | 1 | 2009-07-31 |
| Guangzhou Fortunique , Ltd. | 1 | 2004-11-30 |
| Medline Industries, Inc. | 1 | 2003-09-22 |
| Valumed | 1 | 2003-02-04 |
9 more applicants have MMP clearances. See the full list in Caduvo.
Most recent MMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091178 | Mtp Medical Technical Promotion GmbH | MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN | 2009-07-31 | 100 |
| K043234 | Wrapped IN Comfort | LIGHT DRAPE | 2005-05-25 | 184 |
| K041501 | Guangzhou Fortunique , Ltd. | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | 2004-11-30 | 176 |
| K040794 | Wrapped IN Comfort | INCUBATOR CAPE | 2004-06-10 | 73 |
| K032065 | Medline Industries, Inc. | MEDLINE BAND BAGS AND EQUIPMENT COVERS | 2003-09-22 | 81 |
Recalls for MMP devices
30 product recalls in 13 recall events; 2 initiated in the last five years and 4 still open. Most recent: 2023-05-18.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2020 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code MMP?
MMP is the FDA product code for cover, barrier, protective. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is MMP?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code MMP?
Across 15 cleared submissions the average was 193 days from receipt to decision (median 105).
Which companies have the most MMP clearances?
Wrapped IN Comfort (2); Mtp Medical Technical Promotion GmbH (1); Guangzhou Fortunique , Ltd. (1); Medline Industries, Inc. (1); Valumed (1).
Have MMP devices been recalled?
Yes: 30 product recalls across 13 recall events; the most recent began 2023-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MMP
- Run a recall and safety report across every MMP manufacturer
- Watch product code MMP 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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