510(k) Report

FDA applicant

Emmy Medical

Holliston, ME2 decisions2014–20180 recalls

FDA records 2 decisions for Emmy Medical (Holliston, ME) from 2014 to 2018: 2 510(k) clearances. Most are in product codes FAJ (Cystoscope And Accessories, Flexible/Rigid) and EZL (Catheter, Retention Type, Balloon). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Emmy Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Emmy Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12018: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Emmy Medical by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • EZLCatheter, Retention Type, Balloon1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K142194CytoSure Urinary Access SystemEmmy Medical · 20142cite it

What has FDA decided for it lately?

  • K181346CystoSure Plus CatheterEmmy Medical, LLC · 2018
  • K142194CytoSure Urinary Access SystemEmmy Medical · 2014

The one decision as Emmy Medical →The one decision as Emmy Medical, LLC →