510(k) Report

FDA applicant

Hirata Sangyo Co. USA, Inc.

Mchenry, IL8 decisions1982–19860 recalls

FDA records 8 decisions for Hirata Sangyo Co. USA, Inc. (Mchenry, IL) from 1982 to 1986: 8 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DXN (System, Measurement, Blood-Pressure…). 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 Hirata Sangyo Co. USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hirata Sangyo Co. USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hirata Sangyo Co. USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hirata Sangyo Co. USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRNPump, Infusion3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • HTOReamer1decision
  • GENForceps, General & Plastic Surgery1decision
  • GADRetractor1decision

What has FDA decided for it lately?

  • K864106SR-Model 230 (Modification)Hirata Sangyo Co. USA, Inc. · 1986
  • K842289SR- Model 230Hirata Sangyo Co. USA, Inc. · 1984
  • K833542Surgical InstrumentHirata Sangyo Co. USA, Inc. · 1983
  • K833541Surgical InstrumentHirata Sangyo Co. USA, Inc. · 1983
  • K832686Multiple Manual Surgical InstrumentsHirata Sangyo Co. USA, Inc. · 1983
  • K831583GP-303Hirata Sangyo Co. USA, Inc. · 1983
  • K821989Non-Stetho 7, UM-15TPHirata Sangyo Co. USA, Inc. · 1982
  • K822571Syringe PumpHirata Sangyo Co. USA, Inc. · 1982

All 8 as Hirata Sangyo Co. USA, Inc. →