510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113686Substantially Equivalent

Kimono Microthin with Aqua Lube, Reality Ultra Lubricated

Mayer Laboratories, Berkely CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113686 is the FDA 510(k) clearance record for KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED, a class II device, cleared for Mayer Laboratories, Inc. on under FDA product code HIS (Condom). FDA records list 20 510(k) clearances for Mayer Laboratories, Inc., from to . As of , FDA records show no recalls naming K113686.

Clearance record

Decision date
Received
(82 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mayer Laboratories, Inc. 1950 Addison St., Suite 101, Berkely CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260