510(k) · Cleared
ClearedJO Actively Trying Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Consortium · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Apr 26, 2019 as substantially equivalent to K141132 (Biofilm, Inc., 2015) after a 218-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it.
- Decided
- Apr 26, 2019
- Review
- 218 days
- Class
- Class II
- Product code
- PEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020827 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- 3 generations backK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006 · Recalled
- 2 generations backK072741 Pre-VA Vaginal LubricantIngfertility, LLC · 2008
- 1 generation backK141132 Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015
- This deviceK182585 JO Actively Trying Personal LubricantUnited Consortium · 2019
- Descendant · cites it directly · 0 of its ownK212885 Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022
- Descendant · cites it directly · 0 of its ownK212705 Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| −3 | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | 1 |
| −2 | K072741 | Pre-VA Vaginal Lubricant | Ingfertility, LLC | 2008 | — |
| −1 | K141132 | Astroglide TTC Fertility Friendly Personal Lubricant | Biofilm, Inc. | 2015 | — |
| 0 (this device) | K182585 | JO Actively Trying Personal Lubricant | United Consortium | 2019 | — |
| +1 | K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | 2022 | — |
| +1 | K212705 | Actively Trying Personal Lubricant Unfragrance | CC Wellness, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 K212885 Actively Trying Personal Lubricant Rose Scentedscore 4.0 · 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 |
|---|---|---|---|
| * | K141132 | Astroglide TTC Fertility Friendly Personal LubricantSummary page 4…5. Predicate Device Information Device Name: Astroglide TTC Fertility Friendly Personal Lubricant 510(k) Number: K141132 Manufacturer: Biofilm, Inc. Regulatory Class: Class II Product Code:… | 2015 |
What descends from it? (2)
2 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 17 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K212885 (CC Wellness, LLC, 2022) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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, polyurethane and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182585: JO Actively Trying Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182585
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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