510(k) · Cleared
ClearedRevaree Plus 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 21, 2022 as substantially equivalent to K153372 (Farma-Derma S.R.L., 2016) after a 265-day review. Its family tree reaches back 5 generations to 1981. 3 later devices descend from it.
- Decided
- Jun 21, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
- 2 generations backK094039 Hyalo GynFidia Farmaceutici S.P.A. · 2010
- 1 generation backK153372 Repagyn vaginal suppositoriesFarma-Derma S.R.L. · 2016
- This deviceK213220 Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L. · 2022
- Descendant · cites it directly · 0 of its ownK261909 Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260007 Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid…Hudi Pharma Srl · 2026
- Descendant · cites it directly · 0 of its ownK230518 HydraDose Vaginal SuppositoriesMD Labs, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026 · cites it directly0descendants
- K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl · 2026 · cites it directly0descendants
- K230518HydraDose Vaginal SuppositoriesMD Labs, LLC · 2023 · 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 | K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | 2008 | — |
| −2 | K094039 | Hyalo Gyn | Fidia Farmaceutici S.P.A. | 2010 | — |
| −1 | K153372 | Repagyn vaginal suppositories | Farma-Derma S.R.L. | 2016 | — |
| 0 (this device) | K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | 2022 | — |
| +1 | K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026 | — |
| +1 | K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal… | Hudi Pharma Srl | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153372 | Repagyn vaginal suppositoriesSummary page 5….R.L. REVAREE PLUS VAGINAL SUPPOSITORIES PRE-MARKET NOTIFICATION 510(k) 3. Predicate Device Repagyn vaginal suppositories (K153372) The predicate device has not been subject to a design-related recall. 4. Device Description Farma-Derma’s Revaree pl… | 2016 |
What descends from it? (3)
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 41 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K261909 (PCCA, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Revaree plus 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213220 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213220: Revaree Plus Vaginal Suppositories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213220
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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