510(k) · Cleared
ClearedOne Personal Lubricant (Silicone)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 28, 2012 as substantially equivalent to K062796 (Personal Products Co., 2006) after a 383-day review. Its family tree reaches back 1 generation to 2006. 13 later devices descend from it.
- Decided
- Mar 28, 2012
- Review
- 383 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062796 (2006). 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK062796 K-Y Brand IntriguePersonal Products Co. · 2006
- This deviceK110690 One Personal Lubricant (Silicone)One · 2012
- Descendant · cites it directly · 6 of its ownK130012 Wet Platinum Personal LubricantTrigg Laboratories, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK141913 Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse…Pjur Group Luxembourg S.A. · 2015
- Descendant · cites it directly · 1 of its ownK191654 SILICONE Personal LubricantBath Concept Cosmetics (Dongguan) Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK163395 Astroglide Diamond Silicone Gel Personal LubricantBiofilm, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK211967 Sensual Massage, Ultra PureDreambrands, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130012Wet Platinum Personal LubricantTrigg Laboratories, Inc. · 2013 · cites it directly6descendants
- K141913Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME!Pjur Group Luxembourg S.A. · 2015 · 2 generations on2descendants
- K191654SILICONE Personal LubricantBath Concept Cosmetics (Dongguan) Co., Ltd. · 2020 · cites it directly1descendant
- K163395Astroglide Diamond Silicone Gel Personal LubricantBiofilm, Inc. · 2017 · cites it directly1descendant
- K211967Sensual Massage, Ultra PureDreambrands, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062796 | K-Y Brand Intrigue | Personal Products Co. | 2006 | — |
| 0 (this device) | K110690 | One Personal Lubricant (Silicone) | One | 2012 | — |
| +1 | K130012 | Wet Platinum Personal Lubricant | Trigg Laboratories, Inc. | 2013 | — |
| +2 | K141913 | Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME! | Pjur Group Luxembourg S.A. | 2015 | — |
| +1 | K191654 | SILICONE Personal Lubricant | Bath Concept Cosmetics (Dongguan) Co., Ltd. | 2020 | — |
| +1 | K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Biofilm, Inc. | 2017 | — |
| +2 | K211967 | Sensual Massage, Ultra Pure | Dreambrands, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K062796 | K-Y Brand IntrigueSummary page 1…NUC Predicate Device: K-Y Brand Intrigue Personal Products Co. 5 10(k) No. K062796 Device Description: ONE® SILICONE Personal Lubricant is a non-sterile, personal lubricant… | 2006 |
What descends from it? (13)
See all 135 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® SILICONE 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/K110690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110690: One Personal Lubricant (Silicone).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110690
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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