510(k) Report

510(k) · Cleared

Cleared

K-Y Brand Intrigue Intense Warming Sensation

K072360510(k) TraditionalCleared Dec 12, 2007112-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mcneil-Ppc, Inc. · NUC Lubricant, Personal

Cleared on Dec 12, 2007 after a 112-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Dec 12, 2007
Review
112 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK072360 K-Y Brand Intrigue Intense Warming SensationMcneil-Ppc, Inc. · 2007
  2. Descendant · cites it directly · 5 of its ownK120706 Nirvana a Personal LubricantChurch & Dwight Co., Inc. · 2012
  3. Descendant · 2 generations on · 3 of its ownK161544 Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. · 2016
  4. Descendant · 3 generations on · 2 of its ownK200602 Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 2020
  5. Descendant · 4 generations on · 1 of its ownK200894 Agape Cooling Personal LubricantCC Wellness, LLC · 2020
  6. Descendant · 5 generations on · 0 of its ownK210986 H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant…CC Wellness, LLC · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12016: 12020: 22021: 1
2012high 2 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K120706Nirvana a Personal LubricantChurch & Dwight Co., Inc. · 2012 · cites it directly5descendants
  • K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. · 2016 · 2 generations on3descendants
  • K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 2020 · 3 generations on2descendants
  • K200894Agape Cooling Personal LubricantCC Wellness, LLC · 2020 · 4 generations on1descendant
  • K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…CC Wellness, LLC · 2021 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072360K-Y Brand Intrigue Intense Warming SensationMcneil-Ppc, Inc.2007—
+1K120706Nirvana a Personal LubricantChurch & Dwight Co., Inc.2012—
+2K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc.2016—
+3K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC2020—
+4K200894Agape Cooling Personal LubricantCC Wellness, LLC2020—
+5K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…CC Wellness, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201610
202020
202110
FIG. 1 — Lineage of K072360, 2007–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—K-Y Brand Intrigue
Named without a submission number
—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120706Nirvana a Personal LubricantChurch & Dwight Co., Inc.20125
K123427Nirvana D Personal Lubricant (TBD)Church & Dwight Co., Inc.20130

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, K120706 (Church & Dwight Co., Inc., 2012) has gone furthest, with 5 descendants of its own.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NUC

11in 2025

2007: 52008: 72009: 22010: 42011: 22012: 62013: 112014: 112015: 212016: 142017: 142018: 152019: 132020: 192021: 202022: 142023: 132024: 62025: 112026 (partial year): 12
2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007: 150 days median2008: 271 days median2010: 124 days median2012: 269 days median2013: 205 days median2014: 264 days median2015: 251 days median2016: 181 days median2017: 175 days median2018: 114 days median2019: 150 days median2020: 180 days median2021: 143 days median2022: 112 days median2023: 159 days median2024: 178 days median2025: 221 days median2026 (partial year): 104 days median
2007high 271 (2008) · low 112 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NUC

3in 2013

2008: 12009: 12013: 3
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NUC

13in 2025

2008: 62009: 132010: 22011: 32012: 62013: 52014: 142015: 82016: 142017: 192018: 62019: 82020: 22021: 72022: 72023: 152024: 132025: 13
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007515000
2008727116
20092—113
2010412402
20112—03
2012626906
20131120535
201411264014
20152125108
201614181014
201714175019
20181511406
20191315008
20201918002
20212014307
20221411207
202313159015
20246178013
202511221013
2026121040—

What is it indicated for?

K-Y® Brand Intrigue Intense Warming Sensation is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

Indications for use as stated in the FDA summary.

More from Mcneil-Ppc, Inc.

6 FDA decisions under this applicant name. See the company

  • K081236K-Y Brand Intrigue 2-in-1 Massage CremeMcneil-Ppc, Inc. · 2008
  • K072421K-Y Brand Yours+MineMcneil-Ppc, Inc. · 2008
  • K062535K-Y Brand Touch Massage 2-in-1 TinglingMcneil-Ppc, Inc. · 2007
  • K053397K-Y Brand Sensual MistMcneil-Ppc, Inc. · 2006
  • K023789O.B. TamponsMcneil-Ppc, Inc. · 2002

Recent decisions in NUC

The NUC category page

  • K260117EverslideSpecial Situations, LLC · 2026
  • K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU…Maxigen Biotech, Inc. · 2026
  • K261905BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
  • K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
  • K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026

https://510kreport.com/device/K072360 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072360: K-Y Brand Intrigue Intense Warming Sensation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072360

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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