# K120706: Nirvana a Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Oct 4, 2012 after 210 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K072360 (2007). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072360: K-Y Brand Intrigue Intense Warming Sensation, Mcneil-Ppc, Inc. (2007) Summary page 1.

## Most influential descendants
- K161544: Trojan Chain Reaction Personal Lubricant (2016), 3 descendants of its own
- K200602: Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant (2020), 2 descendants of its own
- K200894: Agape Cooling Personal Lubricant (2020), 1 descendant of its own
- K210986: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit (2021), 0 descendants of its own
- K150886: Trojan Riviera Personal Lubricant (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120706
Methodology: https://510kreport.com/methodology
