510(k) Report

FDA applicant

Schuco, Inc.

Washington, DC2 decisions1993–19940 recalls

FDA records 2 decisions for Schuco, Inc. (Washington, DC) from 1993 to 1994: 2 510(k) clearances. Most are in product codes JCX (Apparatus, Suction, Ward Use, Portable…) and HGX (Pump, Breast, Powered). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Schuco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Schuco, 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?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision
  • HGXPump, Breast, Powered1decision

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.

  • K935218Schuco-Vac Model 178Schuco, Inc. · 19942cite it

What has FDA decided for it lately?

  • K935218Schuco-Vac Model 178Schuco, Inc. · 1994
  • K921261Electric Powered Breast PumpSchuco, Inc. · 1993

All 2 as Schuco, Inc. →