510(k) Report

FDA applicant

Cane S.R.I.

Deer Field, IL2 decisions2002–20020 recalls

FDA records 2 decisions for Cane S.R.I. (Deer Field, IL) in 2002: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). Its devices cite 2 predicates, 0 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 hospital panel, where it files most

How often FDA has decided Cane S.R.I.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cane S.R.I. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cane S.R.I. 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?

  • FRNPump, Infusion2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K013855Microjet Crono HCane S.R.I. · 20021cites it

What has FDA decided for it lately?

  • K013855Microjet Crono HCane S.R.I. · 2002
  • K013776Microjet Model # CD4 and CD4/20Cane S.R.I. · 2002

All 2 as Cane S.R.I. →

Other applicant names beginning “Cane”

FDA records each applicant name separately; these may or may not be the same firm.

Cane S.R.L. 10