510(k) · Cleared
ClearedPre-VA Vaginal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingfertility, LLC · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Jul 16, 2008 as substantially equivalent to K051436 (Ingfertlity, LLC, 2006) after a 293-day review. Its family tree reaches back 2 generations to 2002. 8 later devices descend from it.
- Decided
- Jul 16, 2008
- Review
- 293 days
- Class
- Class II
- Product code
- PEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020827 (2002). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- 1 generation backK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006 · Recalled
- This deviceK072741 Pre-VA Vaginal LubricantIngfertility, LLC · 2008
- Descendant · cites it directly · 3 of its ownK141132 Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK182585 JO Actively Trying Personal LubricantUnited Consortium · 2019
- Descendant · cites it directly · 1 of its ownK162319 BabyDance Fertility LubricantFairhaven Health, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK212885 Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK212705 Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141132Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015 · cites it directly3descendants
- K182585JO Actively Trying Personal LubricantUnited Consortium · 2019 · 2 generations on2descendants
- K162319BabyDance Fertility LubricantFairhaven Health, LLC · 2017 · cites it directly1descendant
- K212885Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022 · 3 generations on0descendants
- K212705Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| −1 | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | 1 |
| 0 (this device) | K072741 | Pre-VA Vaginal Lubricant | Ingfertility, LLC | 2008 | — |
| +1 | K141132 | Astroglide TTC Fertility Friendly Personal Lubricant | Biofilm, Inc. | 2015 | — |
| +2 | K182585 | JO Actively Trying Personal Lubricant | United Consortium | 2019 | — |
| +1 | K162319 | BabyDance Fertility Lubricant | Fairhaven Health, LLC | 2017 | — |
| +3 | K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | 2022 | — |
| +3 | K212705 | Actively Trying Personal Lubricant Unfragrance | CC Wellness, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K051436 | Pre' Vaginal LubricantSummary page 1…e: lubricant, patient, vaginal, latex compatible (21 CFR 884.5300, Product Code NUC) Il. Predicate Devices Predicate Device 510(k) control # Pre’ Vaginal Lubricant | K051436 IV. Description of Device This product is a non-sterile, water-based personal lubricant formulated to supplement the body’s own… | 2006 |
What descends from it? (8)
4 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 6 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K141132 (Biofilm, Inc., 2015) has gone furthest, with 3 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. 2008, 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?
To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions. As a personal lubricant Pre~Va supplements the body’s own natural lubricating fluids, to moisturize, relieve friction and to…
Read the full statement (108 words)
To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions.
As a personal lubricant Pre~Va supplements the body’s own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane 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/K072741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072741: Pre-VA Vaginal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072741
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