510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162319Substantially Equivalent

BabyDance Fertility Lubricant

Fairhaven Health, Bellingham WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162319 is the FDA 510(k) clearance record for BabyDance Fertility Lubricant, a class II device, cleared for Fairhaven Health, LLC on under FDA product code PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible). FDA's definition for product code PEB reads: "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 device may or may not be compatible...". FDA records list 2 510(k) clearances for Fairhaven Health, LLC, from to . As of , FDA records show no recalls naming K162319.

Clearance record

Decision date
Received
(252 days to decision)
Product code
PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Fairhaven Health, LLC 1410 11th St., Bellingham WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEB

Trailing 12 months

FDA records hold no clearances under product code PEB in the trailing twelve months.

FDA records show no clearances under product code PEB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260