510(k) · Cleared
ClearedJO Premium Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium · NUC Lubricant, Personal
Cleared on Jun 11, 2014 as substantially equivalent to K122477 (Ansell Healthcare Products, LLC, 2013) after a 264-day review. Its family tree reaches back 1 generation to 2013. 8 later devices descend from it.
- Decided
- Jun 11, 2014
- Review
- 264 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122477 (2013). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK122477 Lifestyles Luxe Premium Personal LubricantAnsell Healthcare Products, LLC · 2013
- This deviceK132954 JO Premium Personal LubricantUnited Consortium · 2014
- Descendant · cites it directly · 3 of its ownK180083 Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018
- Descendant · 2 generations on · 1 of its ownK212260 Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK151647 UberlubeUberlube, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK260117 EverslideSpecial Situations, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180083Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018 · cites it directly3descendants
- K212260Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022 · 2 generations on1descendant
- K151647UberlubeUberlube, LLC · 2015 · cites it directly1descendant
- K260117EverslideSpecial Situations, LLC · 2026 · 2 generations on0descendants
- K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122477 | Lifestyles Luxe Premium Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| 0 (this device) | K132954 | JO Premium Personal Lubricant | United Consortium | 2014 | — |
| +1 | K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | 2018 | — |
| +2 | K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc. | 2022 | — |
| +1 | K151647 | Uberlube | Uberlube, LLC | 2015 | — |
| +2 | K260117 | Everslide | Special Situations, LLC | 2026 | — |
| +3 | K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122477 | Lifestyles Luxe Premium Personal LubricantSummary page 1…ss: Class 11 Predicate Device: Product Name: LifeStyles Luxe Premium Personal Lubricant 510(k) Number: K(122477 Manufacturer: Ansel[ Healthcare Products, LIC Product Code:… | 2013 |
What descends from it? (8)
4 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?
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
JO Premium Personal Lubricant is a silicone based 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. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132954: JO 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/K132954
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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