510(k) Report

FDA applicant

Help Technologies

Dana Point, CA4 decisions2001–20030 recalls

FDA records 4 decisions for Help Technologies (Dana Point, CA) from 2001 to 2003: 4 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and MEB (Pump, Infusion, Elastomeric). 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 Help Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Help Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Help Technologies 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, Infusion3decisions
  • MEBPump, Infusion, Elastomeric1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K003915Accufuser; Accufuser PlusHelp Technologies · 20013cite it

What has FDA decided for it lately?

  • K023973Automed 3200 Infusion PumpHelp Technologies · 2003
  • K023863Automed 3000 Infusion PumpHelp Technologies · 2003
  • K023491Automed 3300 and 3400 Infusion Pump SystemHelp Technologies · 2002
  • K003915Accufuser; Accufuser PlusHelp Technologies · 2001

All 4 as Help Technologies →