510(k) · Cleared
ClearedCoconut Infused Hybrid Personal 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 Jun 6, 2018 as substantially equivalent to K152918 (Empowered Products, Inc., 2016) after a 79-day review. Its family tree reaches back 1 generation to 2016. 5 later devices descend from it.
- Decided
- Jun 6, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K152918 (2016). 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK152918 Gun Oil, Pink, Gun Oil H2O, Pink WaterEmpowered Products, Inc. · 2016
- This deviceK180712 Coconut Infused Hybrid Personal LubricantUnited Consortium · 2018
- Descendant · cites it directly · 0 of its ownK242162 Coconut HybridGood Clean Love, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK232091 JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC · 2023
- Descendant · cites it directly · 0 of its ownK232090 JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC · 2023
- Descendant · cites it directly · 0 of its ownK221908 JO CUMPLAY Personal LubricantCC Wellness, LLC · 2022
- Descendant · cites it directly · 0 of its ownK210814 Coconu Water Based Personal LubricantCoconu, LLC · 2021
Most influential descendants
Showing 5 of 5 · See all- K242162Coconut HybridGood Clean Love, Inc. · 2024 · cites it directly0descendants
- K232091JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC · 2023 · cites it directly0descendants
- K232090JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC · 2023 · cites it directly0descendants
- K221908JO CUMPLAY Personal LubricantCC Wellness, LLC · 2022 · cites it directly0descendants
- K210814Coconu Water Based Personal LubricantCoconu, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K152918 | Gun Oil, Pink, Gun Oil H2O, Pink Water | Empowered Products, Inc. | 2016 | — |
| 0 (this device) | K180712 | Coconut Infused Hybrid Personal Lubricant | United Consortium | 2018 | — |
| +1 | K242162 | Coconut Hybrid | Good Clean Love, Inc. | 2024 | — |
| +1 | K232091 | JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness, LLC | 2023 | — |
| +1 | K232090 | JO Coconut Hybrid Warming Personal Lubricant | CC Wellness, LLC | 2023 | — |
| +1 | K221908 | JO CUMPLAY Personal Lubricant | CC Wellness, LLC | 2022 | — |
| +1 | K210814 | Coconu Water Based Personal Lubricant | Coconu, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K152918 | Gun Oil, Pink, Gun Oil H2O, Pink WaterSummary page 4…ass: Class II Predicate Device: Product Name: Gun Oil H2O water-based lubricant 510(k) Number: K152918 Manufacturer: Empowered Products, Inc. Product Code:… | 2016 |
What descends from it? (5)
5 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?
- Its one ancestor has no recall.
- Of its descendants, K242162 (Good Clean Love, Inc., 2024) 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. 2018, 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?
Coconut Infused Hybrid 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180712: Coconut Infused Hybrid Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180712
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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