PEB
10 FDA 510(k) clearances · Product code
223 daysmedian time to decision
499 days90th percentile
10clearances measured
FDA profile
- Official device name
- Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Medical specialty
- Obstetrics/Gynecology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Actively Trying Personal Lubricant Rose Scented (K212885) | CC Wellness, LLC | 2022-02-11 |
| Actively Trying Personal Lubricant Unfragrance (K212705) | CC Wellness, LLC | 2022-02-09 |
| Pre-Seed™ Fertility Lubricant (K193450) | Church & Dwight Co., Inc. | 2020-07-23 |
| BioGenesis Fertility Lubricant (K190872) | Good Clean Love, Inc. | 2019-11-07 |
| JO Actively Trying Personal Lubricant (K182585) | United Consortium | 2019-04-26 |
| BabyDance Fertility Lubricant (K162319) | Fairhaven Health, LLC | 2017-04-28 |
| ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT (K141132) | Biofilm, Inc. | 2015-01-09 |
| CONCEIVE PLUS (K131355) | Sasmar, Inc. | 2013-11-07 |
| PRE-VA VAGINAL LUBRICANT (K072741) | Ingfertility, LLC | 2008-07-16 |
| PRE' VAGINAL LUBRICANT (K051436) | Ingfertlity, LLC | 2006-10-13 |
Track PEB automatically
Every clearance here is in the API, with alerts when new ones post.