510(k) · Cleared
ClearedBucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone 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 Sep 18, 2019 as substantially equivalent to K180083 (United Consortium, 2018) after a 169-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Sep 18, 2019
- Review
- 169 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122477 (2013). No later device cites it as a predicate yet.
- 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 deviceK190858 Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant…United Consortium · 2019
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) | K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA… | United Consortium | 2019 | — |
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…icant, personal) 5. Predicate Device Information Device Name: Silicone Personal Lubricant, ALL-IN-ONE 510(k) Number: K180083 Manufacturer: United Consortium Regulatory Class: Class II Product Code:… | 2018 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- 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. 2019, 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?
Bucked Stride Silicone 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms. #LubeLife Thin Silicone Lubricant is a silicone-based…
Read the full statement (168 words)
Bucked Stride Silicone 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Thin Silicone 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
JO XTRA SILKY Ultra-Thin 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190858 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190858: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190858
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