510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203541Substantially Equivalent

Okamoto 002 Lubricated Polyurethane Male Condom

Okamoto U.S.A., Inc., Stratford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203541 is the FDA 510(k) clearance record for Okamoto 002 Lubricated Polyurethane Male Condom, a class II device, cleared for Okamoto USA, Inc. on under FDA product code MOL (Condom, Synthetic). FDA records list 15 510(k) clearances for Okamoto USA, Inc., from to . As of , FDA records show no recalls naming K203541.

Clearance record

Decision date
Received
(449 days to decision)
Product code
MOL Condom, Synthetic
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Okamoto USA, Inc. 18 King St., Stratford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOL

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