510(k) · Cleared
ClearedAgape Cooling 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 Jul 2, 2020 as substantially equivalent to K200602 (CC Wellness, LLC, 2020) after a 90-day review. Its family tree reaches back 4 generations to 2007. 1 later device descends from it.
- Decided
- Jul 2, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K072360 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK072360 K-Y Brand Intrigue Intense Warming SensationMcneil-Ppc, Inc. · 2007
- 3 generations backK120706 Nirvana a Personal LubricantChurch & Dwight Co., Inc. · 2012
- 2 generations backK161544 Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. · 2016
- 1 generation backK200602 Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 2020
- This deviceK200894 Agape Cooling Personal LubricantCC Wellness, LLC · 2020
- Descendant · cites it directly · 0 of its ownK210986 H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant…CC Wellness, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…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 |
|---|---|---|---|---|---|
| −4 | K072360 | K-Y Brand Intrigue Intense Warming Sensation | Mcneil-Ppc, Inc. | 2007 | — |
| −3 | K120706 | Nirvana a Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| −2 | K161544 | Trojan Chain Reaction Personal Lubricant | Church & Dwight Co., Inc. | 2016 | — |
| −1 | K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | CC Wellness, LLC | 2020 | — |
| 0 (this device) | K200894 | Agape Cooling Personal Lubricant | CC Wellness, LLC | 2020 | — |
| +1 | K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife… | CC Wellness, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant Cleared while this submission was under review Summary page 4…: Class II Predicate Device: Product Name: Premium Cooling Personal Lubricant 510(k) Number: K200602 Manufacturer: CC Wellness LLC Product Code: NUC… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife… | 2021 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210986 (CC Wellness, LLC, 2021) has gone furthest, with 0 descendants 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 Cooling 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/K200894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200894: Agape Cooling Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200894
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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