510(k) · Cleared
ClearedLifeStyles® SKYN® Intimate Moments Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sxwell USA, LLC · NUC Lubricant, Personal
Cleared on Dec 15, 2017 as substantially equivalent to K120751 (Church & Dwight Co., Inc., 2012) after a 122-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 15, 2017
- Review
- 122 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890863 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK890863 Trojan for WomenArmkel, LLC · 1989
- 2 generations backK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
- 1 generation backK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
- This deviceK172473 LifeStyles® SKYN® Intimate Moments Personal LubricantSxwell USA, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| −2 | K013614 | Trojan Crystal Clear Liquid | Armkel, LLC | 2002 | — |
| −1 | K120751 | Nirvana B Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| 0 (this device) | K172473 | LifeStyles® SKYN® Intimate Moments Personal Lubricant | Sxwell USA, LLC | 2017 | — |
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 |
|---|---|---|---|
| * | K120751 | Nirvana B Personal LubricantSummary page 4…ass: Class II Product Code: NUC (lubricant, personal) Classification Panel: Obstetrics/Gynecology Primary Predicate Device: 510(K) Number: K120751 Device Name: TROJANTM LUBRICANTS Continuous Silkiness Personal Lubricant Manufacturer: Church & Dwight Co., In… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K120751.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
LifeStyles® SKYN® Intimate Moments Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyisoprene condoms. This product is not compatible with natural rubber latex or polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172473: LifeStyles® SKYN® Intimate Moments 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/K172473
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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