510(k) · Cleared
ClearedKY Banksy Moisture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rb Health (Us), LLC · NUC Lubricant, Personal
Cleared on May 17, 2019 as substantially equivalent to K151884 (Reckitt Benckiser, LLC, 2016) after a 150-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- May 17, 2019
- Review
- 150 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072421 (2008). 4 ancestors in all, the oldest K955648 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK072421 K-Y Brand Yours+MineMcneil-Ppc, Inc. · 2008
- 2 generations backK140193 Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014
- 1 generation backK151884 K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
- This deviceK183505 KY Banksy MoistureRb Health (Us), LLC · 2019
- Descendant · cites it directly · 0 of its ownK200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR…Pjur Group Luxembourg S.A. · 2021
Most influential descendants
Showing 1 of 1 · See all- K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med…Pjur Group Luxembourg S.A. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072421 | K-Y Brand Yours+Mine | Mcneil-Ppc, Inc. | 2008 | — |
| −2 | K140193 | Durex Embrace Personal Lubricant | Reckitt Benckiser, LLC | 2014 | — |
| −1 | K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | 2016 | — |
| 0 (this device) | K183505 | KY Banksy Moisture | Rb Health (Us), LLC | 2019 | — |
| +1 | K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based… | Pjur Group Luxembourg S.A. | 2021 | — |
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 |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K151884 | K-Y Marilyn Pleasure GelSummary page 4…: NUC (lubricant, personal) 5. Predicate Device Information Device Name: KY Marilyn 510(k) Number: K151884 Manufacturer: Reckitt Benckiser LLC Regulatory Class: Class II Product Co… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med… | 2021 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200527 (Pjur Group Luxembourg S.A., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151884.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
This product is intended for penile, vaginal and/or anal application 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/K183505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183505: KY Banksy Moisture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183505
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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