510(k) Report

FDA applicant

Sagami, Inc.

Chicago, IL1 decision1990–19900 recalls

FDA records 1 decision for Sagami, Inc. (Chicago, IL) in 1990: 1 510(k) clearance. All are in product code HIS (Condom). 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 Sagami, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sagami, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • HISCondom1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K897129Condoms (Multiple Brands)Sagami, Inc. · 19902cite it

What has FDA decided for it lately?

  • K897129Condoms (Multiple Brands)Sagami, Inc. · 1990

The one decision as Sagami, Inc. →