510(k) Report

FDA applicant

Stedim, Inc.

Walnut Creek, CA3 decisions1989–19910 recalls

FDA records 3 decisions for Stedim, Inc. (Walnut Creek, CA) from 1989 to 1991: 3 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KPE (Container, I.V.). 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 Stedim, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stedim, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stedim, 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?

  • LHISet, I.V. Fluid Transfer2decisions
  • KPEContainer, I.V.1decision

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.

  • K911567Dual Compartment TPN Bag 3 LiterStedim, Inc. · 19912cite it

What has FDA decided for it lately?

  • K911567Dual Compartment TPN Bag 3 LiterStedim, Inc. · 1991
  • K890204Automix Compounder Vented Spike AdaptorStedim, Inc. · 1989
  • K890205Automix Compounder Y - Adaptor SetStedim, Inc. · 1989

All 3 as Stedim, Inc. →