510(k) Report

FDA applicant

Maryrose Cusimano, Ph.D./Phil Reaston

Sunrise, FL1 decision2002–20020 recalls

FDA records 1 decision for Maryrose Cusimano, Ph.D./Phil Reaston (Sunrise, FL) in 2002: 1 510(k) clearance. All are in product code IKN (Electromyograph, Diagnostic). Its devices cite 5 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, physical medicine panel, where it files most

How often FDA has decided Maryrose Cusimano, Ph.D./Phil Reaston’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maryrose Cusimano, Ph.D./Phil Reaston since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Maryrose Cusimano, Ph.D./Phil Reaston by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maryrose Cusimano, Ph.D./Phil Reaston’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IKNElectromyograph, Diagnostic1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K022719Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 20022cite it

What has FDA decided for it lately?

  • K022719Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002

The one decision as Maryrose Cusimano, Ph.D./Phil Reaston →

Other applicant names beginning “Maryrose”

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

Maryrose Cusimano, Ph.D. & Scott Zeff 1Maryrose 1