510(k) · Cleared
ClearedSensuva Premium Silicone Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valencia Naturals, Inc. · NUC Lubricant, Personal
Cleared on Apr 13, 2022 as substantially equivalent to K180083 (United Consortium, 2018) after a 267-day review. Its family tree reaches back 3 generations to 2013. 1 later device descends from it.
- Decided
- Apr 13, 2022
- Review
- 267 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122477 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK122477 Lifestyles Luxe Premium Personal LubricantAnsell Healthcare Products, LLC · 2013
- 2 generations backK132954 JO Premium Personal LubricantUnited Consortium · 2014
- 1 generation backK180083 Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium · 2018
- This deviceK212260 Sensuva Premium Silicone Personal LubricantValencia Naturals, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122477 | Lifestyles Luxe Premium Personal Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| −2 | K132954 | JO Premium Personal Lubricant | United Consortium | 2014 | — |
| −1 | K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | 2018 | — |
| 0 (this device) | K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K180083 | Silicone Personal Lubricant, ALL-IN-ONESummary page 4…tory Class: Class II Predicate Device: Product Name: Silicone Personal Lubricant 510(k) Number: K180083 Manufacturer: United Consortium Product Code: N… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | 2024 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K234099 (Select Labs, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180083.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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, polyisoprene and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212260: Sensuva Premium Silicone Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212260
Report an extraction error
Are you the manufacturer?
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