FDA applicant

Primus Sterilizer Company, LLC

Omaha, NE6 decisions1994–20230 recalls

FDA records 6 decisions for Primus Sterilizer Company, LLC (Omaha, NE) from 1994 to 2023: 6 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Primus Sterilizer Co., Inc.”.

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 Primus Sterilizer Company, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2007high 2 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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See the 510(k) Report

Other applicant names beginning “Primus”

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

Primus Corp. 14 Primus Gloves Private, Ltd. 4 Primus Gloves Pvt Limited 3 Primus Consulting 1 Primus Corporation Dba Trinity Biotech 1

Primus Sterilizer Company, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Primus”