510(k) · Cleared
ClearedOne Personal Lubricant (Water Based)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 1, 2012 as substantially equivalent to K013086 (Trigg Laboratories, Inc., 2001) after a 327-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Feb 1, 2012
- Review
- 327 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013086 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013086 Wet Light Personal MoisturizerTrigg Laboratories, Inc. · 2001
- This deviceK110691 One Personal Lubricant (Water Based)One · 2012
- Descendant · cites it directly · 2 of its ownK142790 OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK152168 Love Liquid Personal LubricantThe Kama Sutra Company · 2016
- Descendant · 2 generations on · 0 of its ownK220226 X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK220273 Onetouch Non-paraben Lubricant GelThai Nippon Rubber Industry Public Company Limited. · 2022
- Descendant · 2 generations on · 0 of its ownK161385 Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products · 2016
Most influential descendants
Showing 5 of 5 · See all- K142790OneTouch Lubricant GelThai Nippon Rubber Industry Co., Ltd. · 2015 · cites it directly2descendants
- K152168Love Liquid Personal LubricantThe Kama Sutra Company · 2016 · cites it directly1descendant
- K220226X-Y Lubricating JellyR&R Medical Corporation, Ltd. · 2023 · 2 generations on0descendants
- K220273Onetouch Non-paraben Lubricant GelThai Nippon Rubber Industry Public Company Limited. · 2022 · 2 generations on0descendants
- K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013086 | Wet Light Personal Moisturizer | Trigg Laboratories, Inc. | 2001 | — |
| 0 (this device) | K110691 | One Personal Lubricant (Water Based) | One | 2012 | — |
| +1 | K142790 | OneTouch Lubricant Gel | Thai Nippon Rubber Industry Co., Ltd. | 2015 | — |
| +1 | K152168 | Love Liquid Personal Lubricant | The Kama Sutra Company | 2016 | — |
| +2 | K220226 | X-Y Lubricating Jelly | R&R Medical Corporation, Ltd. | 2023 | — |
| +2 | K220273 | Onetouch Non-paraben Lubricant Gel | Thai Nippon Rubber Industry Public Company Limited. | 2022 | — |
| +2 | K161385 | Just Like Me Personal Lubricant | Wtfn-Dba Classic Erotica/Holiday Products | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K013086 | Wet Light Personal MoisturizerSummary page 1…NUC Predicate Device: Wet Light Personal Mvoisturizer Trigg Laboratories 5 10(k) No. K01 3086 Device Description: ONE' Personal Lubricant (water-based formulation) is a non- sterile,… | 2001 |
What descends from it? (5)
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?
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
ONE® Oasis 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/K110691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110691: One Personal Lubricant (Water Based).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110691
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