510(k) · Cleared
ClearedRepagyn vaginal suppositories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Farma-Derma S.R.L. · NUC Lubricant, Personal
Cleared on Jun 30, 2016 as substantially equivalent to K094039 (Fidia Farmaceutici S.P.A., 2010) after a 220-day review. Its family tree reaches back 4 generations to 1981. 4 later devices descend from it.
- Decided
- Jun 30, 2016
- Review
- 220 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810310 (1981). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- 1 generation backK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- This deviceK153372 Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016
- Descendant · cites it directly · 3 of its ownK213220 Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022
- Descendant · 2 generations on · 0 of its ownK261909 Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260007 Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid…Hudi Pharma Srl · 2026
- Descendant · 2 generations on · 0 of its ownK230518 HydraDose Vaginal SuppositoriesMD Labs, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022 · cites it directly3descendants
- K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026 · 2 generations on0descendants
- K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl · 2026 · 2 generations on0descendants
- K230518HydraDose Vaginal SuppositoriesMD Labs, LLC · 2023 · 2 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 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| −1 | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| 0 (this device) | K153372 | Repagyn vaginal suppositories | Farma-Derma S.R.L. | 2016 | — |
| +1 | K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | 2022 | — |
| +2 | K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026 | — |
| +2 | K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal… | Hudi Pharma Srl | 2026 | — |
| +2 | K230518 | HydraDose Vaginal Suppositories | MD Labs, LLC | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K094039 | Hyalo GynSummary page 5…REPAGYN VAGINAL SUPPOSITORIES PRE-MARKET NOTIFICATION 510(k) 3. Predicate Devices Repagyn Vaginal Suppositories are substantially equivalent to Hyalo Gyn, K094039, registered by Fidia Pharmaceuticals. 4. Device Description The Farma-Derma Repagyn Vaginal Suppositories are a non-sterile… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213220 | Revaree Plus Vaginal Suppositories | 2022 | 3 |
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 35 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K213220 (Farma-Derma S.R.L., 2022) has gone furthest, with 3 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. 2016, 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?
Repagyn 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153372: Repagyn vaginal suppositories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153372
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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