510(k) · Cleared
ClearedBioGenesis Fertility Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Clean Love, Inc. · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Nov 7, 2019 as substantially equivalent to K162319 (Fairhaven Health, LLC, 2017) after a 218-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Nov 7, 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). No later device cites it as a predicate yet.
- 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 backK162319 BabyDance Fertility LubricantFairhaven Health, LLC · 2017
- This deviceK190872 BioGenesis Fertility LubricantGood Clean Love, Inc. · 2019
View 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 | K162319 | BabyDance Fertility Lubricant | Fairhaven Health, LLC | 2017 | — |
| 0 (this device) | K190872 | BioGenesis Fertility Lubricant | Good Clean Love, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K162319 | BabyDance Fertility LubricantSummary page 4…ersonal, gamete, fertilization, and embryo compatible) (3) Identification of Predicate Device: BabyDance Fertility Lubricant (K162319) The predicate device has not been subject to a design-related recall. (4) Device Description: BioGenesis Fertility L… | 2017 |
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 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.
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?
BioGenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene…
Read the full statement (97 words)
BioGenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190872: BioGenesis Fertility Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190872
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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