510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K110691Substantially Equivalent

One Personal Lubricant (Water Based)

One, Boston MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110691 is the FDA 510(k) clearance record for ONE PERSONAL LUBRICANT (WATER BASED), a class II device, cleared for One on under FDA product code NUC (Lubricant, Personal). FDA's definition for product code NUC reads: "This device 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. This product may...". FDA records list 2 510(k) clearances for One, from to . As of , FDA records show no recalls naming K110691.

Clearance record

Decision date
Received
(327 days to decision)
Product code
NUC Lubricant, Personal
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
One 12 Channel St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUC

Trailing 12 months
15 clearances under product code NUC in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NUC, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20262
May 20261
June 20263
July 20262
August 20261
September 20262
October 20260