FDA product code QPD: Personal Lubricant Ring
QPD is the FDA product code for personal lubricant ring. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under QPD. The average 510(k) review took 184 days (median 184).
Definition
This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms.
Classification
| Field | Value |
|---|---|
| Device name | Personal Lubricant Ring |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for QPD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 184 |
Compare with all 510(k) review times · Search every QPD clearance
Top QPD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J3 Bioscience, Inc. | 1 | 2021-05-20 |
Most recent QPD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203377 | J3 Bioscience, Inc. | VR101 Lubricating Intravaginal Ring | 2021-05-20 | 184 |
Recalls for QPD devices
openFDA lists no recalls for product code QPD.
Frequently asked questions
What is FDA product code QPD?
QPD is the FDA product code for personal lubricant ring. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is QPD?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPD?
Across 1 cleared submissions the average was 184 days from receipt to decision (median 184).
Which companies have the most QPD clearances?
J3 Bioscience, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPD
- Run a recall and safety report across every QPD manufacturer
- Watch product code QPD 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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