510(k) · Cleared
ClearedAgape Warming Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CC Wellness, LLC · NUC Lubricant, Personal
Cleared on Apr 27, 2020 as substantially equivalent to K183384 (United Consortium, 2019) after a 90-day review. Its family tree reaches back 7 generations to 1990. 5 later devices descend from it.
- Decided
- Apr 27, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K903910 (1990). 11 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 6 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 5 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 4 generations backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- 3 generations backK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- 2 generations backK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- 1 generation backK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
- This deviceK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020
- Descendant · cites it directly · 1 of its ownK203257 LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK243107 Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK212104 Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK210857 Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK210972 H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant…CC Wellness, LLC · 2021
Most influential descendants
Showing 5 of 5 · See all- K203257LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. · 2020 · cites it directly1descendant
- K243107Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd. · 2025 · cites it directly0descendants
- K212104Water-soluble Personal LubricantFoshan Pingchuang Medical Technology Co., Ltd. · 2021 · cites it directly0descendants
- K210857Personal LubricantShenzhen Huanqiu Xuebao Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for…CC Wellness, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −6 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −5 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −4 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| −3 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| −2 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| −1 | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant… | United Consortium | 2019 | — |
| 0 (this device) | K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 | — |
| +1 | K203257 | LUBi Water Based Personal Lubricant | Boya Biotechnology Co., Ltd. | 2020 | — |
| +1 | K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025 | — |
| +1 | K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical Technology Co., Ltd. | 2021 | — |
| +2 | K210857 | Personal Lubricant | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | 2021 | — |
| +1 | K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To… | CC Wellness, LLC | 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 | 1 | 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 |
|---|---|---|---|
| * | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…Summary page 4…Product Name: JO Agape Original Personal Lubricant 510(k) Number: K183384 Manufacturer: CC Wellness LLC Product Code: NUC (lu… | 2019 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K203257 (Boya Biotechnology Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Agape Warming Personal Lubricant is a 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/K200208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200208: Agape Warming Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200208
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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