Pre' Vaginal Lubricant
FDA 510(k) K051436 · Ingfertlity, LLC
510(k) numberK051436
Submission
- Device name
- Pre' Vaginal Lubricant
- Applicant
- Ingfertlity, LLC
Valleyford, WA, US - Received
- June 1, 2005
- Decision date
- October 13, 2006
- 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 |
| K182585 | JO Actively Trying Personal LubricantPEB · Traditional | United Consortium | 04/26/2019SE |
| 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 |
Questions and answers
When was Pre' Vaginal Lubricant cleared by the FDA?
Pre' Vaginal Lubricant (K051436) received a 510(k) decision of Substantially Equivalent on October 13, 2006, 499 days after the submission was received.
What is the product code of K051436?
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.