510(k) · Cleared
ClearedJO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium · NUC Lubricant, Personal
Cleared on Mar 4, 2019 as substantially equivalent to K160211 (Trigg Laboratories D/B/A Wet International, 2016) after an 88-day review. Its family tree reaches back 6 generations to 1990. 6 later devices descend from it.
- Decided
- Mar 4, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903910 (1990). 10 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 5 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 4 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 3 generations backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- 2 generations backK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- 1 generation backK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- This deviceK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
- Descendant · cites it directly · 5 of its ownK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK203257 LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK243107 Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK212104 Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK210857 Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200208Agape Warming Personal LubricantCC Wellness, LLC · 2020 · cites it directly5descendants
- K203257LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020 · 2 generations on1descendant
- K243107Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd. · 2025 · 2 generations on0descendants
- K212104Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K210857Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −5 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −4 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −3 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| −2 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| −1 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| 0 (this device) | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant… | United Consortium | 2019 | — |
| +1 | K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 | — |
| +2 | K203257 | LUBi Water Based Personal Lubricant | Boya Biotechnology Co., Ltd. | 2020 | — |
| +2 | K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025 | — |
| +2 | K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical Technology Co., Ltd. | 2021 | — |
| +3 | K210857 | Personal Lubricant | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUC device
- #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160211 | Wet Original Personal LubricantSummary page 4…e Class: Class II Predicate Device: Product Name: Wet Original® Personal Lubricant 510(k) Number: K160211 Manufacturer: Trigg Laboratories, Inc. Product Code:… | 2016 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200208 | Agape Warming Personal Lubricant | 2020 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 5.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K200208 (CC Wellness, LLC, 2020) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K160211.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
JO Agapé Original Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. MUSE Essence Water-Based Lubricant is a water-based…
Read the full statement (220 words)
JO Agapé Original Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
MUSE Essence Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Water-Based Anal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183384: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183384
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026