510(k) · Cleared
ClearedDurex Embrace Personal Lubricant
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 Nov 4, 2014 as substantially equivalent to K072421 (Mcneil-Ppc, Inc., 2008) after a 281-day review. Its family tree reaches back 1 generation to 2008. 4 later devices descend from it.
- Decided
- Nov 4, 2014
- Review
- 281 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072421 (2008). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK072421 K-Y Brand Yours+MineMcneil-Ppc, Inc. · 2008
- This deviceK140193 Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014
- Descendant · cites it directly · 3 of its ownK151884 K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK183505 KY Banksy MoistureRb Health (Us), LLC · 2019
- Descendant · 3 generations on · 0 of its ownK200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR…Pjur Group Luxembourg S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK163674 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant -…Neo Cosmetique · 2017
Most influential descendants
Showing 4 of 4 · See all- K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016 · cites it directly3descendants
- K183505KY Banksy MoistureRb Health (Us), LLC · 2019 · 2 generations on1descendant
- K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…Pjur Group Luxembourg S.A. · 2021 · 3 generations on0descendants
- K163674Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens…Neo Cosmetique · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072421 | K-Y Brand Yours+Mine | Mcneil-Ppc, Inc. | 2008 | — |
| 0 (this device) | K140193 | Durex Embrace Personal Lubricant | Reckitt Benckiser, LLC | 2014 | — |
| +1 | K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | 2016 | — |
| +2 | K183505 | KY Banksy Moisture | Rb Health (Us), LLC | 2019 | — |
| +3 | K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based… | Pjur Group Luxembourg S.A. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072421 | K-Y Brand Yours+MineSummary page 4…KY Yours + Mine J&J Healthcare Products, Division of McNeil-PPC Inc. 510(k) Document Control Number: K072421 Indication for Use: Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are inten… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151884 | K-Y Marilyn Pleasure Gel | 2016 | 3 |
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, K151884 (Reckitt Benckiser, LLC, 2016) has gone furthest, with 3 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. 2014, 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?
Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are 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. Both lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140193: Durex Embrace 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/K140193
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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