FDA product code MMS: Lubricant, Vaginal, Patient
MMS is the FDA product code for lubricant, vaginal, patient. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the General Hospital panel. Devices under MMS reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for MMS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lubricant, Vaginal, Patient |
| Device class | Class I |
| Regulation | 21 CFR 880.6375 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MMS devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MMS?
MMS is the FDA product code for lubricant, vaginal, patient. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the General Hospital panel.
What device class is MMS?
Class I, regulation 21 CFR 880.6375. Typical premarket route: 510(k).
Have MMS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MMS
- Run a recall and safety report across every MMS manufacturer
- Watch product code MMS 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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