510(k) Report

FDA applicant

Pollenex Associated Mills, Inc.

Walker, MI4 decisions1983–19850 recalls

FDA records 4 decisions for Pollenex Associated Mills, Inc. (Walker, MI) from 1983 to 1985: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and ISA (Massager, Therapeutic, Electric). 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, cardiovascular panel, where it files most

How often FDA has decided Pollenex Associated Mills, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pollenex Associated Mills, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pollenex Associated Mills, 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive3decisions
  • ISAMassager, Therapeutic, Electric1decision

What has FDA decided for it lately?

  • K843010BP-800Pollenex Associated Mills, Inc. · 1985
  • K843446Digital Sphygmomanometer BP-2500Pollenex Associated Mills, Inc. · 1985
  • K843009BP-1000Pollenex Associated Mills, Inc. · 1984
  • K832913Back Massager B-400 AdjustablePollenex Associated Mills, Inc. · 1983

All 4 as Pollenex Associated Mills, Inc. →

Other applicant names beginning “Pollenex”

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

Pollenex Corp. 2