510(k) Report

FDA applicant

San-M Package Co., Ltd.

Shimada-City, JP3 decisions2016–20220 recalls

FDA records 3 decisions for San-M Package Co., Ltd. (Shimada-City, JP) from 2016 to 2022: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and MSH (Respirator, Surgical). Its devices cite 4 predicates, 1 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 and plastic surgery panel, where it files most

How often FDA has decided San-M Package Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 22022: 1
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — San-M Package Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical2decisions
  • MSHRespirator, Surgical1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 1 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.

  • K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 201639cite it
  • K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd. · 20161cites it

What has FDA decided for it lately?

  • K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd. · 2022
  • K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 2016
  • K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd. · 2016

All 3 as San-M Package Co., Ltd. →