Pre-Seed Fertility Lubricant
FDA 510(k) K193450 · Church & Dwight Co., Inc.
Submission
- Device name
- Pre-Seed Fertility Lubricant
- Applicant
- Church & Dwight Co., Inc.
Ewing, NJ, US - Received
- December 13, 2019
- Decision date
- July 23, 2020
- 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 |
| 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 |
| K051436 | Pre' Vaginal LubricantPEB · Traditional | Ingfertlity, LLC | 10/13/2006SE |
More from Ingfertlity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | 02/21/2025SE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | 10/08/2024SE |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condomHIS · Traditional | 09/28/2022SE |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantHIS · Traditional | 07/14/2022SE |
| K203818 | Replens Long-Lasting Vaginal MoisturizerNUC · Traditional | 06/11/2021SE |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)NUC · Traditional | 08/01/2018SE |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate LubricantHIS · Traditional | 03/14/2018SE |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | 08/01/2017SE |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantHIS · Traditional | 09/09/2016SE |
| K161544 | Trojan Chain Reaction Personal LubricantNUC · Traditional | 08/31/2016SE |
Questions and answers
When was Pre-Seed Fertility Lubricant cleared by the FDA?
Pre-Seed Fertility Lubricant (K193450) received a 510(k) decision of Substantially Equivalent on July 23, 2020, 223 days after the submission was received.
What is the product code of K193450?
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.