JO H2O Jelly Original Personal Lubricant
FDA 510(k) K183584 · United Consortium
510(k) numberK183584
Submission
- Device name
- JO H2O Jelly Original Personal Lubricant
- Applicant
- United Consortium
Valencia, CA, US - Received
- December 21, 2018
- Decision date
- April 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
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| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 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 |
| K182585 | JO Actively Trying Personal LubricantPEB · Traditional | 04/26/2019SE |
| 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 H2O Jelly Original Personal Lubricant cleared by the FDA?
JO H2O Jelly Original Personal Lubricant (K183584) received a 510(k) decision of Substantially Equivalent on April 17, 2019, 117 days after the submission was received.
What is the product code of K183584?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.