510(k) · Cleared
Recalled · 2008Pre' Vaginal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingfertlity, LLC · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Oct 13, 2006 as substantially equivalent to K020827 (Personal Products Co., Div. of Mcneil Ppc, Inc., 2002) after a 499-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it. It has been recalled once.
- Decided
- Oct 13, 2006
- Review
- 499 days
- Class
- Class II
- Product code
- PEB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020827 (2002). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- This deviceK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006
- Descendant · cites it directly · 8 of its ownK072741 Pre-VA Vaginal LubricantIngfertility, LLC · 2008
- Descendant · 2 generations on · 3 of its ownK141132 Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK182585 JO Actively Trying Personal LubricantUnited Consortium · 2019
- Descendant · 2 generations on · 1 of its ownK162319 BabyDance Fertility LubricantFairhaven Health, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK212885 Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K072741Pre-VA Vaginal LubricantIngfertility, LLC · 2008 · cites it directly8descendants
- K141132Astroglide TTC Fertility Friendly Personal LubricantBiofilm, Inc. · 2015 · 2 generations on3descendants
- K182585JO Actively Trying Personal LubricantUnited Consortium · 2019 · 3 generations on2descendants
- K162319BabyDance Fertility LubricantFairhaven Health, LLC · 2017 · 2 generations on1descendant
- K212885Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| 0 (this device) | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | — |
| +1 | K072741 | Pre-VA Vaginal Lubricant | Ingfertility, LLC | 2008 | — |
| +2 | K141132 | Astroglide TTC Fertility Friendly Personal Lubricant | Biofilm, Inc. | 2015 | — |
| +3 | K182585 | JO Actively Trying Personal Lubricant | United Consortium | 2019 | — |
| +2 | K162319 | BabyDance Fertility Lubricant | Fairhaven Health, LLC | 2017 | — |
| +4 | K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K020827 | K-Y Brand Ultra Gel Personal LubricantSummary page 1…icant Classification Name: Lubricant, Vaginal, Patient (21 CFR 880.6375, Product Code MMS) Ill. Predicate Devices Predicate Device 510(k) control # K-Y Brand Uitra Gel K020827 IV. Description of Device This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own… | 2002 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072741 | Pre-VA Vaginal Lubricant | 2008 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2008 | Not classified | Z-0626-2009 | Pending | Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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 a diagnostic or therapeutic devices including fertility interventions.
As a personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also 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/K051436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051436: Pre' Vaginal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051436
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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