510(k) · Cleared
ClearedK-Y Brand Intrigue 2-in-1 Massage Creme
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 Sep 25, 2008 after a 147-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 25, 2008
- Review
- 147 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK081236 K-Y Brand Intrigue 2-in-1 Massage CremeMcneil-Ppc, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143511 K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal…Reckitt Benckiser · 2015
Most influential descendants
Showing 1 of 1 · See all- K143511K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantReckitt Benckiser · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081236 | K-Y Brand Intrigue 2-in-1 Massage Creme | Mcneil-Ppc, Inc. | 2008 | — |
| +1 | K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | Reckitt Benckiser | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | — | K-Y® Brand Touch Massage™ 2-in-1 Warming body massage + Personal lubricant Named without a submission number |
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 |
|---|---|---|---|
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | 2015 | 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?
- Of its descendants, K143511 (Reckitt Benckiser, 2015) 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. 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 Intrigue™ 2-in-1 Massage Creme™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is compatible with latex condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081236 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081236: K-Y Brand Intrigue 2-in-1 Massage Creme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081236
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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