510(k) · Cleared
ClearedK-Y Marilyn Pleasure Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reckitt Benckiser, LLC · NUC Lubricant, Personal
Cleared on Jan 11, 2016 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 186-day review. Its family tree reaches back 2 generations to 2008. 3 later devices descend from it.
- Decided
- Jan 11, 2016
- Review
- 186 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K072421 (2008). 3 ancestors in all, the oldest K955648 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK072421 K-Y Brand Yours+MineMcneil-Ppc, Inc. · 2008
- 1 generation backK140193 Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014
- This deviceK151884 K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
- Descendant · cites it directly · 1 of its ownK183505 KY Banksy MoistureRb Health (Us), LLC · 2019
- Descendant · 2 generations on · 0 of its ownK200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR…Pjur Group Luxembourg S.A. · 2021
- Descendant · cites it directly · 0 of its ownK163674 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant -…Neo Cosmetique · 2017
Most influential descendants
Showing 3 of 3 · See all- K183505KY Banksy MoistureRb Health (Us), LLC · 2019 · cites it directly1descendant
- K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…Pjur Group Luxembourg S.A. · 2021 · 2 generations on0descendants
- K163674Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens…Neo Cosmetique · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072421 | K-Y Brand Yours+Mine | Mcneil-Ppc, Inc. | 2008 | — |
| −1 | K140193 | Durex Embrace Personal Lubricant | Reckitt Benckiser, LLC | 2014 | — |
| 0 (this device) | K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | 2016 | — |
| +1 | K183505 | KY Banksy Moisture | Rb Health (Us), LLC | 2019 | — |
| +2 | K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based… | Pjur Group Luxembourg S.A. | 2021 | — |
| +1 | K163674 | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera… | Neo Cosmetique | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 4…tion Name: Lubricant (21 CFR §884.5300, Product Code NUC) Predicate Device(s): KY® Brand Liquid Reckitt Benckiser LLC Product Code: NUC 510(k) No.: K955648 Durex® Embrace Warming Sensation Gel Reckitt Benckiser LLC Product Code: NUC 510(k) No.: K140193… | 1996 |
| * | K140193 | Durex Embrace Personal LubricantSummary page 4…Product Code: NUC 510(k) No.: K955648 Durex® Embrace Warming Sensation Gel Reckitt Benckiser LLC Product Code: NUC 510(k) No.: K140193 Durex® Embrace Tingling Experience Gel Reckitt Benckiser LLC Product Code: NUC 510(k) No.: K140193… | 2014 |
What descends from it? (3)
2 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 8 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183505 (Rb Health (Us), LLC, 2019) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K955648.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Intended 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 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/K151884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151884: K-Y Marilyn Pleasure Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151884
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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