JO Actively Trying Personal Lubricant
FDA 510(k) K182585 · United Consortium
Submission
- Device name
- JO Actively Trying Personal Lubricant
- Applicant
- United Consortium
Valencia, CA, US - Received
- September 20, 2018
- Decision date
- April 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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…
Other 510(k)s with product code PEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212885 | Actively Trying Personal Lubricant Rose ScentedPEB · Traditional | CC Wellness, LLC | 02/11/2022SE |
| K212705 | Actively Trying Personal Lubricant UnfragrancePEB · Traditional | CC Wellness, LLC | 02/09/2022SE |
| K193450 | Pre-Seed Fertility LubricantPEB · Traditional | Church & Dwight Co., Inc. | 07/23/2020SE |
| K190872 | BioGenesis Fertility LubricantPEB · Traditional | Good Clean Love, Inc. | 11/07/2019SE |
| K162319 | BabyDance Fertility LubricantPEB · Traditional | Fairhaven Health, LLC | 04/28/2017SE |
| K141132 | Astroglide TTC Fertility Friendly Personal LubricantPEB · Traditional | Biofilm, Inc. | 01/09/2015SE |
| K131355 | Conceive PlusPEB · Traditional | Sasmar, Inc. | 11/07/2013SE |
| K072741 | Pre-Va Vaginal LubricantPEB · Traditional | Ingfertility, LLC | 07/16/2008SE |
| K051436 | Pre' Vaginal LubricantPEB · Traditional | Ingfertlity, LLC | 10/13/2006SE |
More from Ingfertlity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K192203 | JO for Him H2O Gel Original Personal LubricantNUC · Traditional | 02/10/2020SE |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY…NUC · Traditional | 09/18/2019SE |
| K191214 | JO Premium Jelly Original Personal LubricantNUC · Traditional | 08/01/2019SE |
| K183584 | JO H2O Jelly Original Personal LubricantNUC · Traditional | 04/17/2019SE |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…NUC · Traditional | 03/04/2019SE |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…NUC · Traditional | 11/14/2018SE |
| K181408 | JO Classic Hybrid Personal LubricantNUC · Traditional | 08/27/2018SE |
| K180712 | Coconut Infused Hybrid Personal LubricantNUC · Traditional | 06/06/2018SE |
| K180219 | JO H2O Flavored Personal LubricantsNUC · Traditional | 04/20/2018SE |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONENUC · Traditional | 04/09/2018SE |
Questions and answers
When was JO Actively Trying Personal Lubricant cleared by the FDA?
JO Actively Trying Personal Lubricant (K182585) received a 510(k) decision of Substantially Equivalent on April 26, 2019, 218 days after the submission was received.
What is the product code of K182585?
The FDA product code is PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, a Class II (moderate risk) device regulated under 21 CFR 884.5300.