510(k) Report

FDA applicant

Amplife Corporation

Great Neck, NY4 decisions2004–20050 recalls

FDA records 4 decisions for Amplife Corporation (Great Neck, NY) from 2004 to 2005: 4 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). 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 Amplife Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amplife Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amplife Corporation 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?

  • FLLContinuous Measurement Thermometer2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K050413Amplief Wrist Blood Pressure Monitor, Model M600Amplife Corporation · 2005
  • K043550Amplife Upper Arm Blood Pressure Monitor, Model M100Amplife Corporation · 2005
  • K042906Amplife Digital Infrared Ear Thermometer, Model E101Amplife Corporation · 2004
  • K042575Amplife Digital Clinical ThermometerAmplife Corporation · 2004

All 4 as Amplife Corporation →