510(k) · Cleared
ClearedK-Y Brand Yours+Mine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcneil-Ppc, Inc. · NUC Lubricant, Personal
Cleared on Mar 6, 2008 after a 191-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Mar 6, 2008
- Review
- 191 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK072421 K-Y Brand Yours+MineMcneil-Ppc, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK140193 Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK151884 K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK183505 KY Banksy MoistureRb Health (Us), LLC · 2019
- Descendant · 4 generations on · 0 of its ownK200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR…Pjur Group Luxembourg S.A. · 2021
- Descendant · 3 generations on · 0 of its ownK163674 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant -…Neo Cosmetique · 2017
Most influential descendants
Showing 5 of 5 · See all- K140193Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014 · cites it directly4descendants
- K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016 · 2 generations on3descendants
- K183505KY Banksy MoistureRb Health (Us), LLC · 2019 · 3 generations on1descendant
- K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…Pjur Group Luxembourg S.A. · 2021 · 4 generations on0descendants
- K163674Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens…Neo Cosmetique · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072421 | K-Y Brand Yours+Mine | Mcneil-Ppc, Inc. | 2008 | — |
| +1 | K140193 | Durex Embrace Personal Lubricant | Reckitt Benckiser, LLC | 2014 | — |
| +2 | K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | 2016 | — |
| +3 | K183505 | KY Banksy Moisture | Rb Health (Us), LLC | 2019 | — |
| +4 | K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based… | Pjur Group Luxembourg S.A. | 2021 | — |
| +3 | K163674 | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera… | Neo Cosmetique | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140193 | Durex Embrace Personal Lubricant | 2014 | 4 |
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?
- Of its descendants, K140193 (Reckitt Benckiser, LLC, 2014) has gone furthest, with 4 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. 2008, 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?
K-Y® Brand YOURS+MINE TM is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072421: K-Y Brand Yours+Mine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072421
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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