510(k) · Cleared
ClearedFor Play, Slip, Prepair - Personal Lubricants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trimensa Pharmaceuticals · NUC Lubricant, Personal
Cleared on Jul 12, 2006 as substantially equivalent to K033076 (Ansell Healthcare, Inc., 2003) and 1 other predicate after a 384-day review. Its family tree reaches back 3 generations to 1981. 3 later devices descend from it.
- Decided
- Jul 12, 2006
- Review
- 384 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810310 (1981). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 1 generation backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- This deviceK051688 For Play, Slip, Prepair - Personal LubricantsTrimensa Pharmaceuticals · 2006
- Descendant · cites it directly · 2 of its ownK110325 Aqua LubeMayer Laboratories, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK150841 Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal…Laclede, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK162235 Luvena Vaginal Moisturizer & LubricantLaclede, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K110325Aqua LubeMayer Laboratories, Inc. · 2011 · cites it directly2descendants
- K150841Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal LubricantLaclede, Inc. · 2015 · 2 generations on1descendant
- K162235Luvena Vaginal Moisturizer & LubricantLaclede, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −2 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −1 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| 0 (this device) | K051688 | For Play, Slip, Prepair - Personal Lubricants | Trimensa Pharmaceuticals | 2006 | — |
| +1 | K110325 | Aqua Lube | Mayer Laboratories, Inc. | 2011 | — |
| +2 | K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | Laclede, Inc. | 2015 | — |
| +3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033076 | Lifestyles Liquid Personal LubricantSummary page 2…ir Personal Lubricant(s) Predicated Devices: Lifestyles Liquid Personal Lubricant, Ansell Healthcare, Inc. K033076 K-Y Liquid Personal Lubricant McNei[-PPC, Inc. K… | 2003 |
| * | K955648 | K-Y Personal LubricantSummary page 2…Ansell Healthcare, Inc. K033076 K-Y Liquid Personal Lubricant McNei[-PPC, Inc. K955648 TRIMENSA / 510(k) P… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110325 | Aqua Lube | 2011 | 2 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110325 (Mayer Laboratories, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K033076.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ForPlay, SLIP and PrePair personal Lubricants are medical devices intended
for medical purposes to lubricate a body orifice to facilitate entry of diagnostic
or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are
recommended as personal lubricants and are principally intended to supplement
the body's natural lubrication, to moisturize and enhance the comfort and
ease of intimacy with or without a condom.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051688: For Play, Slip, Prepair - Personal Lubricants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051688
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