FDA applicant

Sterile Design, Inc.

Oldsmar, FL10 decisions1979–19941 recall

FDA records 10 decisions for Sterile Design, Inc. (Oldsmar, FL) from 1979 to 1994: 10 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and JOD (Filter, Blood, Cardiotomy Suction Line…). 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Sterile Design, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sterile”

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

Sterile Concepts, Inc. 10 Sterile Containment Technology, LLC 1 Sterile Medical Systems 1

Sterile Design, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sterile”