510(k) · Cleared
ClearedNirvana a Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · NUC Lubricant, Personal
Cleared on Oct 4, 2012 as substantially equivalent to K072360 (Mcneil-Ppc, Inc., 2007) after a 210-day review. Its family tree reaches back 1 generation to 2007. 5 later devices descend from it.
- Decided
- Oct 4, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072360 (2007). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK072360 K-Y Brand Intrigue Intense Warming SensationMcneil-Ppc, Inc. · 2007
- This deviceK120706 Nirvana a Personal LubricantChurch & Dwight Co., Inc. · 2012
- Descendant · cites it directly · 3 of its ownK161544 Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK200602 Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK200894 Agape Cooling Personal LubricantCC Wellness, LLC · 2020
- Descendant · 4 generations on · 0 of its ownK210986 H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant…CC Wellness, LLC · 2021
- Descendant · cites it directly · 0 of its ownK150886 Trojan Riviera Personal LubricantChurch & Dwight Co., Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. · 2016 · cites it directly3descendants
- K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 2020 · 2 generations on2descendants
- K200894Agape Cooling Personal LubricantCC Wellness, LLC · 2020 · 3 generations on1descendant
- K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…CC Wellness, LLC · 2021 · 4 generations on0descendants
- K150886Trojan Riviera Personal LubricantChurch & Dwight Co., Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072360 | K-Y Brand Intrigue Intense Warming Sensation | Mcneil-Ppc, Inc. | 2007 | — |
| 0 (this device) | K120706 | Nirvana a Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| +1 | K161544 | Trojan Chain Reaction Personal Lubricant | Church & Dwight Co., Inc. | 2016 | — |
| +2 | K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | CC Wellness, LLC | 2020 | — |
| +3 | K200894 | Agape Cooling Personal Lubricant | CC Wellness, LLC | 2020 | — |
| +4 | K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife… | CC Wellness, LLC | 2021 | — |
| +1 | K150886 | Trojan Riviera Personal Lubricant | Church & Dwight Co., Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K072360 | K-Y Brand Intrigue Intense Warming SensationSummary page 1…NUC -Condom (21 C.F.R. § 884.5300) Classification: Class 11 Predicate Device: K-Y® Brand Intrigue TM Intense Warming Sensation (1K072360) Intended Use: Tingly Warmth is a personal lubricant for penile and/or vaginal… | 2007 |
What descends from it? (5)
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?
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
TINGLY WARMTH is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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. Not compatible with polyurethane or other condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120706: Nirvana a Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120706
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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