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510(k) K952393

OKAMOTO CONDOM by Okamoto USA, Inc. — Product Code HIS

K952393 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "OKAMOTO CONDOM". The FDA issued a decision of Substantially Equivalent on August 9, 1995. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Okamoto USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1995
Date Received
May 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Okamoto USA, Inc.

  • K252622 — Male Latex Condom HA (May 4, 2026)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K203541 — Okamoto 002 Lubricated Polyurethane Male Condom (February 25, 2022)
  • K192669 — Extremely Thin 003, ZERO ZERO THREE (July 24, 2020)
  • K141256 — OKAMOTO STUDDED CONDOM (July 23, 2014)
  • K140379 — MEGA BIG BOY CONDOM (July 1, 2014)
  • K090259 — OKAMOTO ULTRA THIN (March 31, 2009)
  • K902804 — EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT (August 13, 1990)
  • K896339 — MODIFIED LABELING ON OKAMOTO HARMONY CONDOM (January 10, 1990)
  • K884402 — EXTRA STRENGTH SKIN LESS SKIN CONDOM (March 10, 1989)

Other clearances for product code HIS

  • K252622 — Male Latex Condom HA (May 4, 2026)
  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)

FDA data resources