510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K865106Substantially Equivalent

Prophylactic (Condom) Mr. Johnny

Medelec Intl. Corp., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K865106 is the FDA 510(k) clearance record for PROPHYLACTIC (CONDOM) MR. JOHNNY, a class II device, cleared for Medelec Intl. Corp. on under FDA product code HIS (Condom). FDA records list 15 510(k) clearances for Medelec Intl. Corp., from to . As of , FDA records show no recalls naming K865106.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medelec Intl. Corp. One Lincoln Rd., Suite 304, Miami Beach FL
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