510(k) · Cleared
ClearedNirvana B 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 3, 2012 as substantially equivalent to K013614 (Armkel, LLC, 2002) after a 205-day review. Its family tree reaches back 2 generations to 1989. 6 later devices descend from it.
- Decided
- Oct 3, 2012
- Review
- 205 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890863 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK890863 Trojan for WomenArmkel, LLC · 1989
- 1 generation backK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
- This deviceK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
- Descendant · cites it directly · 4 of its ownK181408 JO Classic Hybrid Personal LubricantUnited Consortium · 2018
- Descendant · 2 generations on · 3 of its ownK191480 Wet Water Based Personal Lubricant (additionally, branded as WET…Trigg Laboratories, Inc. D/B/A Wet International · 2019
- Descendant · 3 generations on · 1 of its ownK212000 MedleyGood Clean Love, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK222567 Playground For All Love SeshPlayground For All · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181408JO Classic Hybrid Personal LubricantUnited Consortium · 2018 · cites it directly4descendants
- K191480Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…Trigg Laboratories, Inc. D/B/A Wet International · 2019 · 2 generations on3descendants
- K212000MedleyGood Clean Love, Inc. · 2021 · 3 generations on1descendant
- K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC · 2024 · 3 generations on0descendants
- K222567Playground For All Love SeshPlayground For All · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| −1 | K013614 | Trojan Crystal Clear Liquid | Armkel, LLC | 2002 | — |
| 0 (this device) | K120751 | Nirvana B Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| +1 | K181408 | JO Classic Hybrid Personal Lubricant | United Consortium | 2018 | — |
| +2 | K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum… | Trigg Laboratories, Inc. D/B/A Wet International | 2019 | — |
| +3 | K212000 | Medley | Good Clean Love, Inc. | 2021 | — |
| +3 | K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | 2024 | — |
| +4 | K222567 | Playground For All Love Sesh | Playground For All | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K013614 | Trojan Crystal Clear LiquidSummary page 1…NUC - Condom (21 C.F.R. § 884.5300) Classification: Class 11 Predicate Device: TROJANTM Crystal Clear Liquid (K0136 14) Intended Use: [Continuous Silkiness - Warm & Tingling] [Continuous Silkiness]… | 2002 |
What descends from it? (6)
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181408 (United Consortium, 2018) has gone furthest, with 4 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. 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?
[Continuous Silkiness - Warm & Tingling] [Continuous Silkiness] 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/K120751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120751: Nirvana B 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/K120751
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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