510(k) · Cleared
ClearedBabyDance Fertility Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fairhaven Health, LLC · PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Cleared on Apr 28, 2017 as substantially equivalent to K072741 (Ingfertility, LLC, 2008) after a 252-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Apr 28, 2017
- Review
- 252 days
- Class
- Class II
- Product code
- PEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020827 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK020827 K-Y Brand Ultra Gel Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
- 2 generations backK051436 Pre' Vaginal LubricantIngfertlity, LLC · 2006 · Recalled
- 1 generation backK072741 Pre-VA Vaginal LubricantIngfertility, LLC · 2008
- This deviceK162319 BabyDance Fertility LubricantFairhaven Health, LLC · 2017
- Descendant · cites it directly · 0 of its ownK190872 BioGenesis Fertility LubricantGood Clean Love, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190872BioGenesis Fertility LubricantGood Clean Love, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020827 | K-Y Brand Ultra Gel Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | 2002 | — |
| −2 | K051436 | Pre' Vaginal Lubricant | Ingfertlity, LLC | 2006 | 1 |
| −1 | K072741 | Pre-VA Vaginal Lubricant | Ingfertility, LLC | 2008 | — |
| 0 (this device) | K162319 | BabyDance Fertility Lubricant | Fairhaven Health, LLC | 2017 | — |
| +1 | K190872 | BioGenesis Fertility Lubricant | Good Clean Love, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K072741 | Pre-VA Vaginal LubricantSummary page 4…Personal, Gamete, Fertilization, and Embryo Compatible 510(k) Number: K162319 III. Predicate Device Pre-Va Vaginal Lubricant (K072741), manufactured by INGFertility, LLC. This predicate device has not been subject to any design related recalls. IV. Description o… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190872 | BioGenesis Fertility Lubricant | 2019 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K190872 (Good Clean Love, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072741.
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. 2017, 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?
BabyDance 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. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms.
BabyDance 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/K162319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162319: BabyDance 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/K162319
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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