510(k) · Cleared
ClearedThe Sex Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Necessaire, Inc. · NUC Lubricant, Personal
Cleared on Sep 10, 2018 as substantially equivalent to K130345 (Mayer Laboratories, Inc., 2013) after a 139-day review. Its family tree reaches back 4 generations to 1981. 5 later devices descend from it.
- Decided
- Sep 10, 2018
- Review
- 139 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810310 (1981). 5 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- 1 generation backK130345 Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc. · 2013
- This deviceK181078 The Sex GelNecessaire, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK221328 Bloomi Smooth Water Based LubricantThe Bloomi Inc.. · 2022
- Descendant · cites it directly · 0 of its ownK254011 Flow Water-Based Personal LubricantLBDO Group, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242958 Joylux Intimacy Gel (PG3100)Joylux, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242645 INA Moisturizing Intimate Lubricant Water-Based Personal LubricantProject Chemistry, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK230674 JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based…CC Wellness, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K221328Bloomi Smooth Water Based LubricantThe Bloomi Inc.. · 2022 · cites it directly1descendant
- K254011Flow Water-Based Personal LubricantLBDO Group, Inc. · 2026 · cites it directly0descendants
- K242958Joylux Intimacy Gel (PG3100)Joylux, Inc. · 2025 · 2 generations on0descendants
- K242645INA Moisturizing Intimate Lubricant Water-Based Personal LubricantProject Chemistry, Inc. · 2024 · cites it directly0descendants
- K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant…CC Wellness, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −3 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −2 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| −1 | K130345 | Aqua Lube Natural Lubricant - Regular, Warming | Mayer Laboratories, Inc. | 2013 | — |
| 0 (this device) | K181078 | The Sex Gel | Necessaire, Inc. | 2018 | — |
| +1 | K221328 | Bloomi Smooth Water Based Lubricant | The Bloomi Inc.. | 2022 | — |
| +1 | K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026 | — |
| +2 | K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | 2025 | — |
| +1 | K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Project Chemistry, Inc. | 2024 | — |
| +1 | K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick… | CC Wellness, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K130345 | Aqua Lube Natural Lubricant - Regular, WarmingSummary page 4…ice Class: Class II Predicate Devices Aqua Lube Natural Lubricants Personal Lubricant 510(k) Number: K130345 Manufacturer: Mayer Laboratories, Inc. Product Code: NUC Device Class:… | 2013 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221328 | Bloomi Smooth Water Based Lubricant | 2022 | 1 |
| K254011 | Flow Water-Based Personal Lubricant | 2026 | 0 |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | 2024 | 0 |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant… | 2023 | 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 37 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221328 (The Bloomi Inc.., 2022) has gone furthest, with 1 descendant of its own.
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?
The Sex Gel 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 compatible
with natural latex, polyisoprene, and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181078: The Sex Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181078
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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