510(k) · Cleared
ClearedReplens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lil Drug Store Products, Inc. · NUC Lubricant, Personal
Cleared on Aug 17, 2010 as substantially equivalent to K062682 (Lake Consumer Products, Inc., 2007) after a 105-day review. Its family tree reaches back 3 generations to 1981. 7 later devices descend from it.
- Decided
- Aug 17, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810310 (1981). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 1 generation backK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- This deviceK101241 Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Lil Drug Store Products, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK112217 ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R)…Polichem S.A · 2012
- Descendant · 2 generations on · 1 of its ownK143349 GynomunalPolichem S.A · 2015
- Descendant · 2 generations on · 1 of its ownK132772 Lubrigyn CreamUniderm Farmaceutici Srl · 2014
- Descendant · 3 generations on · 0 of its ownK232040 GynatrofTyros Biopharma, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK203377 VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K112217ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal…Polichem S.A · 2012 · cites it directly4descendants
- K143349GynomunalPolichem S.A · 2015 · 2 generations on1descendant
- K132772Lubrigyn CreamUniderm Farmaceutici Srl · 2014 · 2 generations on1descendant
- K232040GynatrofTyros Biopharma, Inc. · 2024 · 3 generations on0descendants
- K203377VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc. · 2021 · cites it directly0descendants
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 | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| 0 (this device) | K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) | Lil Drug Store Products, Inc. | 2010 | — |
| +1 | K112217 | ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting… | Polichem S.A | 2012 | — |
| +2 | K143349 | Gynomunal | Polichem S.A | 2015 | — |
| +2 | K132772 | Lubrigyn Cream | Uniderm Farmaceutici Srl | 2014 | — |
| +3 | K232040 | Gynatrof | Tyros Biopharma, Inc. | 2024 | — |
| +1 | K203377 | VR101 Lubricating Intravaginal Ring | J3 Bioscience, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K062682 | CVS Personal Lubricant and MoisturizerSummary page 1…lass: 2 Review Panel: Obstetrics/Gynecology Predicate Device: Device Name: CVS Personal Lubricant & Moisturizer 510(k) Number: K(062682 Product Code: NUC, MMS Intended Use: Replens is a personal lubricant for vaginal application, intended to mo… | 2007 |
What descends from it? (7)
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 29 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112217 (Polichem S.A, 2012) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K062682.
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?
Replens 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 natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101241: Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101241
Report an extraction error
Are you the manufacturer?
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