510(k) · Cleared
ClearedHyaloGYN Vaginal Hydrating Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fidia Farmaceutici S.P.A. · NUC Lubricant, Personal
Cleared on Sep 1, 2015 as substantially equivalent to K094039 (Fidia Farmaceutici S.P.A., 2010) and 2 other predicates after a 152-day review. Its family tree reaches back 4 generations to 1981. 9 later devices descend from it.
- Decided
- Sep 1, 2015
- Review
- 152 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K810310 (1981). 11 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- 1 generation backK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- This deviceK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · cites it directly · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK241443 Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil…Hathor Professional Skincare, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261177 PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK261292 PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal…PR Personal Care Laboratories · 2026
- Descendant · 3 generations on · 0 of its ownK252914 Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · cites it directly6descendants
- K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd. · 2025 · 2 generations on1descendant
- K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026 · 2 generations on0descendants
- K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories · 2026 · 2 generations on0descendants
- K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −3 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −2 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| −1 | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| 0 (this device) | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +1 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +2 | K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe… | Hathor Professional Skincare, Ltd. | 2025 | — |
| +2 | K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | Pinkslip, LLC | 2026 | — |
| +2 | K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026 | — |
| +3 | K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare, Ltd. | 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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K094039 | Hyalo GynSummary page 4…C (lubricant, personal) Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed: • HyaloGYN® Vaginal Hydrating Gel, Fidia Farmaceutici, S.p.A. - K094039 Legally Marketed Reference Device Used to Support Substantial Equivalence: • Replens Long-Lasting Vaginal Moisturizer, Lil’ D… | 2010 |
| * | K101098 | Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035Summary page 4….A. - K094039 Legally Marketed Reference Device Used to Support Substantial Equivalence: • Replens Long-Lasting Vaginal Moisturizer, Lil’ Drug Store Products, Inc. - K101098 • Elegance Woman's Lubricant, Elegance - K070587 Description of Device: HyaloGYN is a line extension to add a formulation of H… | 2010 |
| * | K070587 | Elegance Woman's LubricantSummary page 4…ed to Support Substantial Equivalence: • Replens Long-Lasting Vaginal Moisturizer, Lil’ Drug Store Products, Inc. - K101098 • Elegance Woman's Lubricant, Elegance - K070587 Description of Device: HyaloGYN is a line extension to add a formulation of HyaloGYN not made with parabens. It is a non- steril… | 2008 |
What descends from it? (9)
3 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?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 9.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K211998 (Good Clean Love, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K094039.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
HyaloGYN® is a personal lubricant for 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 polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150883: HyaloGYN Vaginal Hydrating Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150883
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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