FDA product code PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
PEB is the FDA product code for lubricant, personal, gamete, fertilization, and embryo compatible. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 10 510(k) submissions under PEB, 2 in the last five years, from 9 different applicants. The average 510(k) review took 246 days (median 220).
Definition
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
Classification
| Field | Value |
|---|---|
| Device name | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| 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 PEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 252 |
| 2019 | 2 | 218 |
| 2020 | 1 | 223 |
| 2022 | 2 | 160 |
Compare with all 510(k) review times · Search every PEB clearance
Top PEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CC Wellness, LLC | 2 | 2022-02-11 |
| Church & Dwight Co., Inc. | 1 | 2020-07-23 |
| Good Clean Love, Inc. | 1 | 2019-11-07 |
| United Consortium | 1 | 2019-04-26 |
| Fairhaven Health, LLC | 1 | 2017-04-28 |
4 more applicants have PEB clearances. See the full list in Caduvo.
Most recent PEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212885 | CC Wellness, LLC | Actively Trying Personal Lubricant Rose Scented | 2022-02-11 | 154 |
| K212705 | CC Wellness, LLC | Actively Trying Personal Lubricant Unfragrance | 2022-02-09 | 167 |
| K193450 | Church & Dwight Co., Inc. | Pre-Seed Fertility Lubricant | 2020-07-23 | 223 |
| K190872 | Good Clean Love, Inc. | BioGenesis Fertility Lubricant | 2019-11-07 | 218 |
| K182585 | United Consortium | JO Actively Trying Personal Lubricant | 2019-04-26 | 218 |
Recalls for PEB devices
openFDA lists no recalls for product code PEB.
Frequently asked questions
What is FDA product code PEB?
PEB is the FDA product code for lubricant, personal, gamete, fertilization, and embryo compatible. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is PEB?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEB?
Across 10 cleared submissions the average was 246 days from receipt to decision (median 220).
Which companies have the most PEB clearances?
CC Wellness, LLC (2); Church & Dwight Co., Inc. (1); Good Clean Love, Inc. (1); United Consortium (1); Fairhaven Health, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PEB
- Run a recall and safety report across every PEB manufacturer
- Watch product code PEB 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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