510(k) · Cleared
ClearedSilicone Personal Lubricant, ALL-IN-ONE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium · NUC Lubricant, Personal
Cleared on Apr 9, 2018 as substantially equivalent to K132954 (United Consortium, 2014) after an 88-day review. Its family tree reaches back 2 generations to 2013. 3 later devices descend from it.
- Decided
- Apr 9, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K122477 (2013). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK122477 Lifestyles Luxe Premium Personal LubricantAnsell Healthcare Products, LLC · 2013
- 1 generation backK132954 JO Premium Personal LubricantUnited Consortium · 2014
- This deviceK180083 Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018
- Descendant · cites it directly · 1 of its ownK212260 Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
- Descendant · cites it directly · 0 of its ownK190858 Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant…United Consortium · 2019
Most influential descendants
Showing 3 of 3 · See all- K212260Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022 · cites it directly1descendant
- K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC · 2024 · 2 generations on0descendants
- K190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY…United Consortium · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122477 | Lifestyles Luxe Premium Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| −1 | K132954 | JO Premium Personal Lubricant | United Consortium | 2014 | — |
| 0 (this device) | K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | 2018 | — |
| +1 | K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc. | 2022 | — |
| +2 | K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | 2024 | — |
| +1 | K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA… | United Consortium | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K132954 | JO Premium Personal LubricantSummary page 4…Class II Predicate Device: Product Name: JO Premium Personal Lubricant 510(k) Number: K132954 Manufacturer: United Consortium Product Code: NUC… | 2014 |
What descends from it? (3)
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 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212260 (Valencia Naturals, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K132954.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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, polyurethane and polyisoprene condoms.
ALL-IN-ONE is a silicone-based personal lubricant for penile, anal 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, polyurethane and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180083: Silicone Personal Lubricant, ALL-IN-ONE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180083
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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