510(k) · Cleared
ClearedSelect Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Select Labs, LLC · NUC Lubricant, Personal
Cleared on Jun 7, 2024 as substantially equivalent to K191480 (Trigg Laboratories, Inc. D/B/A Wet International, 2019) and 1 other predicate after a 164-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Jun 7, 2024
- Review
- 164 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K890863 (1989). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK890863 Trojan for WomenArmkel, LLC · 1989
- 4 generations backK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
- 3 generations backK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
- 2 generations backK181408 JO Classic Hybrid Personal LubricantUnited Consortium · 2018
- 1 generation backK191480 Wet Water Based Personal Lubricant (additionally, branded as WET…Trigg Laboratories, Inc. D/B/A Wet International · 2019
- This deviceK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890863 | Trojan for Women | Armkel, LLC | 1989 | — |
| −4 | K013614 | Trojan Crystal Clear Liquid | Armkel, LLC | 2002 | — |
| −3 | K120751 | Nirvana B Personal Lubricant | Church & Dwight Co., Inc. | 2012 | — |
| −2 | K181408 | JO Classic Hybrid Personal Lubricant | United Consortium | 2018 | — |
| −1 | K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum… | Trigg Laboratories, Inc. D/B/A Wet International | 2019 | — |
| 0 (this device) | K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…Summary page 5…Select Hybrid Personal Select Pure Silicone Lubricant Lubricant Predicate 510(k) Number K191480 K212260 Predicate Trade Name Wet® Water Based Personal Sensuva Premium Silicone… | 2019 |
| * | K212260 | Sensuva Premium Silicone Personal LubricantSummary page 5…Select Pure Silicone Lubricant Lubricant Predicate 510(k) Number K191480 K212260 Predicate Trade Name Wet® Water Based Personal Sensuva Premium Silicone L… | 2022 |
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 35 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K191480.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Select Hybrid 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Select Pure Silicone 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234099: Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234099
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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