510(k) Report

FDA applicant

Helps Products, Inc.

Orlando, FL4 decisions1988–19880 recalls

FDA records 4 decisions for Helps Products, Inc. (Orlando, FL) in 1988: 4 510(k) clearances. Most are in product codes GIO (Tube, Collection, Capillary Blood) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). 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, hematology panel, where it files most

How often FDA has decided Helps Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Helps Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Helps Products, 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?

  • GIOTube, Collection, Capillary Blood2decisions
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph1decision
  • GHYHematocrit, Tube, Rack, Sealer, Holder1decision

What has FDA decided for it lately?

  • K881188Blood PH Capillary Tubes, HeparinHelps Products, Inc. · 1988
  • K881186Microhematocrit Tubes, Heparin & Microhema Tube,PLHelps Products, Inc. · 1988
  • K881187Natelson Tubes, Heparin and PlainHelps Products, Inc. · 1988
  • K881262Caraway Tubes, Heparin and PlainHelps Products, Inc. · 1988

All 4 as Helps Products, Inc. →