510(k) · Cleared
ClearedHydraDose Vaginal Suppositories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MD Labs, LLC · NUC Lubricant, Personal
Cleared on Jun 23, 2023 as substantially equivalent to K213220 (Farma-Derma S.R.L., 2022) after a 116-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Jun 23, 2023
- Review
- 116 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- 3 generations backK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- 2 generations backK153372 Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016
- 1 generation backK213220 Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022
- This deviceK230518 HydraDose Vaginal SuppositoriesMD Labs, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| −3 | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| −2 | K153372 | Repagyn vaginal suppositories | Farma-Derma S.R.L. | 2016 | — |
| −1 | K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | 2022 | — |
| 0 (this device) | K230518 | HydraDose Vaginal Suppositories | MD Labs, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K213220 | Revaree Plus Vaginal SuppositoriesSummary page 4…III. Predicate Device Predicate Device 510(k) Number Revaree Plus Vaginal Suppositories K213220 This predicate device has not been subject to a design-related recall. IV. Description of Device HydraDos… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K213220.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
HydraDose Vaginal Suppositories are 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 as stated in the FDA summary.
https://510kreport.com/device/K230518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230518: HydraDose Vaginal Suppositories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230518
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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