FDA applicant

Sterile Containment Technology, LLC

Point Richmond, CA1 decision2006–20061 recall

FDA records 1 decision for Sterile Containment Technology, LLC (Point Richmond, CA) in 2006: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Sterile Containment Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterile Containment Technology, LLC since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sterile Containment Technology, LLC’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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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 Design, Inc. 10 Sterile Medical Systems 1

Sterile Containment Technology, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sterile”