510(k) Report

FDA applicant

Otter (China) Technology Co., Ltd.

Stillwater, MN1 decision2004–20040 recalls

FDA records 1 decision for Otter (China) Technology Co., Ltd. (Stillwater, MN) in 2004: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). 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 Otter (China) Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Otter (China) Technology Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Otter (China) Technology Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Otter (China) Technology Co., Ltd.’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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Which product codes does it file in?

  • MEGSyringe, Antistick1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K040545Otter Safety SyringeOtter (China) Technology Co., Ltd. · 20042cite it

What has FDA decided for it lately?

  • K040545Otter Safety SyringeOtter (China) Technology Co., Ltd. · 2004

The one decision as Otter (China) Technology Co., Ltd. →