510(k) · Cleared
ClearedCVS Personal Lubricant and Moisturizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Consumer Products, Inc. · NUC Lubricant, Personal
Cleared on Apr 4, 2007 as substantially equivalent to K935299 (Biofilm, Inc., 1994) after a 208-day review. Its family tree reaches back 2 generations to 1981. 27 later devices descend from it.
- Decided
- Apr 4, 2007
- Review
- 208 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810310 (1981). 27 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 1 generation backK935299 AstroglideBiofilm, Inc. · 1994
- This deviceK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK101098 Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable…Lil Drug Store Products, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · cites it directly · 7 of its ownK101241 Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Lil Drug Store Products, Inc. · 2010
- Descendant · 3 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK112217 ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R)…Polichem S.A · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K101098Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035Lil Drug Store Products, Inc. · 2010 · cites it directly17descendants
- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · 2 generations on9descendants
- K101241Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Lil Drug Store Products, Inc. · 2010 · cites it directly7descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 3 generations on6descendants
- K112217ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal…Polichem S.A · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −1 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| 0 (this device) | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| +1 | K101098 | Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator)… | Lil Drug Store Products, Inc. | 2010 | — |
| +2 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +1 | K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) | Lil Drug Store Products, Inc. | 2010 | — |
| +3 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +1 | K112217 | ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting… | Polichem S.A | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K935299 | AstroglideSummary page 1…ember 6, 2006 Proprietary Name: CVS Personal Lubricant & Moisturizer Common Name: Predicate Name: Classification Name: Personal Lubricant Astroglide 510(k) Number: K935299 21 CFR 880.6375 Patient Vaginal Lubricant Product Code MMS Class I 21 CFR880.5300 Lubricant, Patient, Vaginal, Latex Compatible… | 1994 |
What descends from it? (27)
See all 274 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101098 | Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035 | 2010 | 17 |
| K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) | 2010 | 7 |
| K112217 | ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal… | 2012 | 4 |
| K140304 | Simply Slick Personal Lubricating Lotion | 2014 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101098 (Lil Drug Store Products, Inc., 2010) has gone furthest, with 17 descendants of its own.
- 11 other devices also cite its predicate K935299.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.
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/K062682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062682: CVS Personal Lubricant and Moisturizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062682
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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