510(k) · Cleared
ClearedKY Banksy Aloe
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 Apr 16, 2019 after a 140-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Apr 16, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK183302 KY Banksy AloeRb Health (Us), LLC · 2019
- Descendant · cites it directly · 1 of its ownK211088 Grosz Play FeelRb Health (Us), LLC · 2021
- Descendant · cites it directly · 1 of its ownK201186 KY Grosz JellyRb Health (Us), LLC · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK230781 Belle SensilubeRb Health (Us), LLC · 2023
- Descendant · 2 generations on · 0 of its ownK213400 Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play…Rb Health (Us) · 2022
- Descendant · 2 generations on · 0 of its ownK200730 pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K211088Grosz Play FeelRb Health (Us), LLC · 2021 · cites it directly1descendant
- K201186KY Grosz JellyRb Health (Us), LLC · 2020 · cites it directly1descendant
- K230781Belle SensilubeRb Health (Us), LLC · 2023 · cites it directly0descendants
- K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play…Rb Health (Us) · 2022 · 2 generations on0descendants
- K200730pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183302 | KY Banksy Aloe | Rb Health (Us), LLC | 2019 | — |
| +1 | K211088 | Grosz Play Feel | Rb Health (Us), LLC | 2021 | — |
| +1 | K201186 | KY Grosz Jelly | Rb Health (Us), LLC | 2020 | 1 |
| +1 | K230781 | Belle Sensilube | Rb Health (Us), LLC | 2023 | — |
| +2 | K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry… | Rb Health (Us) | 2022 | — |
| +2 | K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | Pjur Group Luxembourg S.A. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 0 |
| 2021 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
5 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?
- Of its descendants, K211088 (Rb Health (Us), LLC, 2021) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K183302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183302: KY Banksy Aloe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183302
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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