FDA applicant

Andersen Sterilizers, Inc.

Haw River, NC19 decisions2015–20220 recalls

FDA records 19 decisions for Andersen Sterilizers, Inc. (Haw River, NC) from 2015 to 2022: 19 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and JOJ (Indicator, Physical/Chemical Sterilization…). Since 2016 its 510(k)s took a median of 261 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 12 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 Andersen Sterilizers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015high 6 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Andersen Sterilizers, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Andersen Sterilizers, Inc.’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 “Andersen”

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

Andersen Products, Inc. 2

Andersen Sterilizers, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Andersen”