510(k) · Cleared
ClearedHyalo Gyn
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 May 7, 2010 as substantially equivalent to K072647 (Biofilm, Inc., 2008) after a 128-day review. Its family tree reaches back 3 generations to 1981. 19 later devices descend from it.
- Decided
- May 7, 2010
- Review
- 128 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810310 (1981). 4 ancestors in all. 19 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 1 generation backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- This deviceK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- Descendant · cites it directly · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · 2 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK153372 Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016
- Descendant · 2 generations on · 3 of its ownK213220 Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022
- Descendant · cites it directly · 2 of its ownK141718 Internal Hydrating GelCombe Incorporated · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · cites it directly9descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 2 generations on6descendants
- K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016 · cites it directly4descendants
- K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022 · 2 generations on3descendants
- K141718Internal Hydrating GelCombe Incorporated · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −2 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −1 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| 0 (this device) | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| +1 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +2 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +1 | K153372 | Repagyn vaginal suppositories | Farma-Derma S.R.L. | 2016 | — |
| +2 | K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | 2022 | — |
| +1 | K141718 | Internal Hydrating Gel | Combe Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K072647 | Glycerin & Paraben Free AstroglideSummary page 1…Classification: 21 C.F.R. § 884.5300 Predicate Glycerin & Paraben Free Astroglide Device: Bioflim, Inc. K072647 Device HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel Description: that contains "Hydeal-… | 2008 |
What descends from it? (19)
See all 194 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 29 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K150883 (Fidia Farmaceutici S.P.A., 2015) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K072647.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
HYALO GYN is a personal lubricant, or 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094039: Hyalo Gyn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094039
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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