510(k) Report

FDA applicant

Okamoto USA, Inc.

Washington, DC15 decisions1987–20260 recalls

FDA records 15 decisions for Okamoto USA, Inc. (Washington, DC) from 1987 to 2026: 15 510(k) clearances. Most are in product codes HIS (Condom) and MOL (Condom, Synthetic). Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Okamoto USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12014: 22020: 12022: 12025: 12026 (partial year): 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Okamoto USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Okamoto USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HISCondom14decisions
  • MOLCondom, Synthetic1decision

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192669Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 20202cite it
  • K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. · 20221cites it
  • K140379Mega Big Boy CondomOkamoto USA, Inc. · 20141cites it
  • K090259Okamoto Ultra ThinOkamoto USA, Inc. · 20091cites it
  • K872812Skinless-Skin, Pink Tint (Condom)Okamoto USA, Inc. · 19871cites it

What has FDA decided for it lately?

  • K252622Male Latex Condom HAOkamoto USA, Inc. · 2026
  • K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc. · 2025
  • K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. · 2022
  • K192669Extremely Thin 003, ZERO ZERO THREEOkamoto USA, Inc. · 2020
  • K141256Okamoto Studded CondomOkamoto USA, Inc. · 2014
  • K140379Mega Big Boy CondomOkamoto USA, Inc. · 2014
  • K090259Okamoto Ultra ThinOkamoto USA, Inc. · 2009
  • K952393Okamoto CondomOkamoto USA, Inc. · 1995

All 15 as Okamoto USA, Inc. →