510(k) Report

FDA applicant

Seirin-America, Inc.

Weymouth, MA4 decisions1996–19970 recalls

FDA records 4 decisions for Seirin-America, Inc. (Weymouth, MA) from 1996 to 1997: 4 510(k) clearances. All are in product code MQX (Needle, Acupuncture, Single Use). 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 Seirin-America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seirin-America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Seirin-America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQXNeedle, Acupuncture, Single Use4decisions

Who builds on its devices?

Later devices cite its devices 8 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.

  • K962809Seirin Acupuncture NeedlesSeirin-America, Inc. · 19964cite it
  • K970254Seirin Pyonex Acupuncture NeedlesSeirin-America, Inc. · 19972cite it
  • K963769Seirin Spinex Intradermal Acupuncture NeedlesSeirin-America, Inc. · 19962cite it

What has FDA decided for it lately?

  • K970260Seirin JR Acupuncture NeedlesSeirin-America, Inc. · 1997
  • K970254Seirin Pyonex Acupuncture NeedlesSeirin-America, Inc. · 1997
  • K963769Seirin Spinex Intradermal Acupuncture NeedlesSeirin-America, Inc. · 1996
  • K962809Seirin Acupuncture NeedlesSeirin-America, Inc. · 1996

All 4 as Seirin-America, Inc. →