510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203377Substantially Equivalent

VR101 Lubricating Intravaginal Ring

J3 Bioscience, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203377 is the FDA 510(k) clearance record for VR101 Lubricating Intravaginal Ring, a class II device, cleared for J3 Bioscience, Inc. on under FDA product code QPD (Personal Lubricant Ring). FDA's definition for product code QPD reads: "This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be...". FDA records list one 510(k) clearance for J3 Bioscience, Inc. As of , FDA records show no recalls naming K203377.

Clearance record

Decision date
Received
(184 days to decision)
Product code
QPD Personal Lubricant Ring
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
J3 Bioscience, Inc. 825 N. 300 W., Suite N231, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPD

Trailing 12 months

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

FDA records show no clearances under product code QPD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPD, 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