510(k) Report

FDA applicant

Special Medical Co., Ltd.

Great Neck, NY1 decision2003–20030 recalls

FDA records 1 decision for Special Medical Co., Ltd. (Great Neck, NY) in 2003: 1 510(k) clearance. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 3 predicates, 0 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, general hospital panel, where it files most

How often FDA has decided Special Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Special Medical Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Special Medical Co., Ltd.’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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K021130Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 20031cites it

What has FDA decided for it lately?

  • K021130Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003

The one decision as Special Medical Co., Ltd. →

Other applicant names beginning “Special”

FDA records each applicant name separately; these may or may not be the same firm.

Special Health Systems, Ltd. 3Special Devices, Inc. 2Special Machinery Co. 1Special Products, Inc. 1Special Situations, LLC 1