FDA product code MSC: Barrier, Std, Oral Sex
MSC is the FDA product code for barrier, std, oral sex. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 7 510(k) submissions under MSC, 3 in the last five years, from 7 different applicants. The average 510(k) review took 223 days (median 234); 236 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Std, Oral Sex |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MSC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 227 |
| 2022 | 2 | 246 |
| 2026 | 1 | 236 |
Compare with all 510(k) review times · Search every MSC clearance
Top MSC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luwi, LLC | 1 | 2026-07-14 |
| Brazen Goods Inc. Dba Lorals | 1 | 2022-04-22 |
| Sanctuary Health Sdn. Bhd. | 1 | 2022-03-28 |
| Pamco Distributing, Inc. | 1 | 2021-08-05 |
| Line One Laboratories, Inc. | 1 | 2010-02-05 |
2 more applicants have MSC clearances. See the full list in Caduvo.
Most recent MSC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253662 | Luwi, LLC | LIXI (LXOSFM1) | 2026-07-14 | 236 |
| K212928 | Brazen Goods Inc. Dba Lorals | Lorals | 2022-04-22 | 220 |
| K212037 | Sanctuary Health Sdn. Bhd. | SancDam Latex Oral Dam | 2022-03-28 | 271 |
| K203727 | Pamco Distributing, Inc. | Harmony Latex Dam, Harmony Non-Latex Dam | 2021-08-05 | 227 |
| K091769 | Line One Laboratories, Inc. | TRUST DAM | 2010-02-05 | 234 |
Recalls for MSC devices
openFDA lists no recalls for product code MSC.
Frequently asked questions
What is FDA product code MSC?
MSC is the FDA product code for barrier, std, oral sex. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is MSC?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSC?
Across 7 cleared submissions the average was 223 days from receipt to decision (median 234).
Which companies have the most MSC clearances?
Luwi, LLC (1); Brazen Goods Inc. Dba Lorals (1); Sanctuary Health Sdn. Bhd. (1); Pamco Distributing, Inc. (1); Line One Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSC
- Run a recall and safety report across every MSC manufacturer
- Watch product code MSC 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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