510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041432Substantially Equivalent

Astroglide Brand Warming Liquid Personal Lubricant

Biofilm, Inc., Vista CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041432 is the FDA 510(k) clearance record for ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT, a class II device, cleared for Biofilm, Inc. on under FDA product code HIS (Condom). FDA records list 17 510(k) clearances for Biofilm, Inc., from to . As of , FDA records show no recalls naming K041432.

Clearance record

Decision date
Received
(186 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Biofilm, Inc. 3225 Executive Ridge, Vista 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