510(k) · Cleared
ClearedLifestyles Luxe Premium Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · NUC Lubricant, Personal
Cleared on Feb 19, 2013 after a 189-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 13 later devices descend from it.
- Decided
- Feb 19, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
13 later devices descend from it, 3 citing it directly.
- This deviceK122477 Lifestyles Luxe Premium Personal LubricantAnsell Healthcare Products, LLC · 2013
- Descendant · cites it directly · 8 of its ownK132954 JO Premium Personal LubricantUnited Consortium · 2014
- Descendant · 2 generations on · 3 of its ownK180083 Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018
- Descendant · cites it directly · 2 of its ownK162569 YES oil-based Personal Lubricant, YES Water-based Personal…Biotech Lubricants, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK212260 Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK191411 Ah!Yes Ob Coco Personal LubricantBio-Tech Lubricants, Ltd. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K132954JO Premium Personal LubricantUnited Consortium · 2014 · cites it directly8descendants
- K180083Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018 · 2 generations on3descendants
- K162569YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal…Biotech Lubricants, Ltd. · 2017 · cites it directly2descendants
- K212260Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022 · 3 generations on1descendant
- K191411Ah!Yes Ob Coco Personal LubricantBio-Tech Lubricants, Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122477 | Lifestyles Luxe Premium Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| +1 | K132954 | JO Premium Personal Lubricant | United Consortium | 2014 | — |
| +2 | K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | 2018 | — |
| +1 | K162569 | YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES… | Biotech Lubricants, Ltd. | 2017 | — |
| +3 | K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc. | 2022 | — |
| +2 | K191411 | Ah!Yes Ob Coco Personal Lubricant | Bio-Tech Lubricants, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0851288 | Viclle Lubricant Number could not be read |
What descends from it? (13)
See all 133 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?
- Of its descendants, K132954 (United Consortium, 2014) has gone furthest, with 8 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. 2013, 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® LuxeTM Premium 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 natural rubber latex, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122477: Lifestyles Luxe Premium 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/K122477
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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