510(k) · Cleared
ClearedActively Trying Personal Lubricant Rose Scented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CC Wellness, LLC · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Feb 11, 2022 as substantially equivalent to K182585 (United Consortium, 2019) after a 154-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Feb 11, 2022
- Review
- 154 days
- Class
- Class II
- Product code
- PEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K020827 (2002). No later device cites it as a predicate yet.
- Root · 5 generations backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- 4 generations backK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006 · Recalled
- 3 generations backK072741 Pre-VA Vaginal LubricantIngfertility, LLC · 2008
- 2 generations backK141132 Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015
- 1 generation backK182585 JO Actively Trying Personal LubricantUnited Consortium · 2019
- This deviceK212885 Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| −4 | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | 1 |
| −3 | K072741 | Pre-VA Vaginal Lubricant | Ingfertility, LLC | 2008 | — |
| −2 | K141132 | Astroglide TTC Fertility Friendly Personal Lubricant | Biofilm, Inc. | 2015 | — |
| −1 | K182585 | JO Actively Trying Personal Lubricant | United Consortium | 2019 | — |
| 0 (this device) | K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | 2022 | — |
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 PEB? 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 PEB device
- #1 K212705 Actively Trying Personal Lubricant Unfragrancescore 4.0 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K182585 | JO Actively Trying Personal LubricantSummary page 4…Condom Regulatory Class: II Product Code: PEB 5. Predicate Device Information Device Name: Actively Trying Personal Lubricant 510(k) Number: K182585 Manufacturer: CC Wellness LLC Regulatory Class: Class II Product Code: PEB (lubricant, personal, gamete, fertil… | 2019 |
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 20 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K182585.
How does its category compare?
All PEB devicesPEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PEB
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PEB
Too few PEB 510(k)s in any year since 2007 to give a median.
Recalls per year · PEB
No recall names PEB since 2007.
Adverse event reports per year · PEB
1in 2025
MAUDE reports naming product code PEB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to
lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication.
This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product
is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane
condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212885: Actively Trying Personal Lubricant Rose Scented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212885
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