510(k) · Cleared
ClearedAqua Lube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mayer Laboratories, Inc. · NUC Lubricant, Personal
Cleared on Dec 8, 2011 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 1 other predicate after a 308-day review. Its family tree reaches back 4 generations to 1981. 2 later devices descend from it.
- Decided
- Dec 8, 2011
- Review
- 308 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K810310 (1981). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- 1 generation backK051688 For Play, Slip, Prepair - Personal LubricantsTrimensa Pharmaceuticals · 2006
- This deviceK110325 Aqua LubeMayer Laboratories, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK150841 Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal…Laclede, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK162235 Luvena Vaginal Moisturizer & LubricantLaclede, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| −1 | K051688 | For Play, Slip, Prepair - Personal Lubricants | Trimensa Pharmaceuticals | 2006 | — |
| 0 (this device) | K110325 | Aqua Lube | Mayer Laboratories, Inc. | 2011 | — |
| +1 | K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | Laclede, Inc. | 2015 | — |
| +2 | K162235 | Luvena Vaginal Moisturizer & Lubricant | Laclede, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…, Lubricant, patient, vaginal, latex compatible Predicate Device K-Y® Personal Lubricant (K(955648) ForPlay Personal Lubricant (1(051688) Description of Device… | 1996 |
| * | K051688 | For Play, Slip, Prepair - Personal LubricantsSummary page 1…ompatible Predicate Device K-Y® Personal Lubricant (K(955648) ForPlay Personal Lubricant (1(051688) Description of Device Aqua Lube® is a non-sterile, water-based, personal… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | 2015 | 1 |
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 30 years and passes through 5 companies; a new generation was cleared every 9.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150841 (Laclede, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K955648.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Aqua Lube 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 compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110325: Aqua Lube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110325
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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