510(k) · Cleared
ClearedDesnuda Reflect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Clean Love, Inc. · NUC Lubricant, Personal
Cleared on Nov 18, 2021 as substantially equivalent to K150883 (Fidia Farmaceutici S.P.A., 2015) after a 143-day review. Its family tree reaches back 5 generations to 1981. 6 later devices descend from it.
- Decided
- Nov 18, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 12 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- 2 generations backK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- 1 generation backK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- This deviceK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK241443 Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil…Hathor Professional Skincare, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK261177 PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
- Descendant · cites it directly · 0 of its ownK261292 PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal…PR Personal Care Laboratories · 2026
- Descendant · 2 generations on · 0 of its ownK252914 Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK254101 Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd. · 2025 · cites it directly1descendant
- K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026 · cites it directly0descendants
- K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories · 2026 · cites it directly0descendants
- K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd. · 2026 · 2 generations on0descendants
- K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc. · 2026 · cites it directly0descendants
View 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 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| −2 | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| −1 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| 0 (this device) | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +1 | K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe… | Hathor Professional Skincare, Ltd. | 2025 | — |
| +1 | K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | Pinkslip, LLC | 2026 | — |
| +1 | K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026 | — |
| +2 | K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare, Ltd. | 2026 | — |
| +1 | K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 4 | 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 K213220 Revaree Plus Vaginal Suppositoriesscore 13.7 · 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 |
|---|---|---|---|
| * | K150883 | HyaloGYN Vaginal Hydrating GelSummary page 4…00 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC (lubricant, personal) Predicate Device: K150883, HyaloGYN® Vaginal Hydrating Gel Fidia Farmaceutici, S.p.A. The predicate device has not been sub… | 2015 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla… | 2025 | 1 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | 2026 | 0 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | 2026 | 0 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | 2026 | 0 |
| K250629 | Sutil Rich Personal Lubricant | 2025 | 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 40 years and passes through 6 companies; a new generation was cleared every 7.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K241443 (Hathor Professional Skincare, Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K150883.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Desnuda Reflect 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/K211998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211998: Desnuda Reflect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211998
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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