510(k) · Cleared
ClearedOneTouch Lubricant Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thai Nippon Rubber Industry Co., Ltd. · NUC Lubricant, Personal
Cleared on Jul 30, 2015 as substantially equivalent to K110691 (One, 2012) and 1 other predicate after a 307-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.
- Decided
- Jul 30, 2015
- Review
- 307 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K810310 (1981). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 2 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 1 generation backK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
- This deviceK142790 OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK220226 X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220273 Onetouch Non-paraben Lubricant GelThai Nippon Rubber Industry Public Company Limited. · 2022
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 |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −2 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −1 | K122476 | Lifestyles Smooth 2-in-1 Massage & Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| 0 (this device) | K142790 | OneTouch Lubricant Gel | Thai Nippon Rubber Industry Co., Ltd. | 2015 | — |
| +1 | K220226 | X-Y Lubricating Jelly | R&R Medical Corporation, Ltd. | 2023 | — |
| +1 | K220273 | Onetouch Non-paraben Lubricant Gel | Thai Nippon Rubber Industry Public Company Limited. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K110691 | One Personal Lubricant (Water Based)Summary page 4…ice Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) Global Protection Corp. [ONE® Oasis (K110691)] Ansell Healthcare Products [LifeStyles® Smooth™ 2-in-I Massage & Lubricant (K122476)] 6. Device Description One Touch™ L… | 2012 |
| * | K122476 | Lifestyles Smooth 2-in-1 Massage & LubricantSummary page 4…5. Legally Marketed Predicate Device(s) Global Protection Corp. [ONE® Oasis (K110691)] Ansell Healthcare Products [LifeStyles® Smooth™ 2-in-I Massage & Lubricant (K122476)] 6. Device Description One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. (“TNR”) are a line of perso… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 34 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K220226 (R&R Medical Corporation, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110691.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
OneTouch™ Lubricant 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 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/K142790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142790: OneTouch Lubricant Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142790
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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