510(k) Report

FDA applicant

H R Pharmaceuticals, Inc.

York, PA2 decisions2018–20200 recalls

FDA records 2 decisions for H R Pharmaceuticals, Inc. (York, PA) from 2018 to 2020: 2 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and MUI (Media, Coupling, Ultrasound). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided H R Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — H R Pharmaceuticals, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like H R Pharmaceuticals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EZLCatheter, Retention Type, Balloon1decision
  • MUIMedia, Coupling, Ultrasound1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 20184cite it

What has FDA decided for it lately?

  • K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. · 2020
  • K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018

All 2 as H R Pharmaceuticals, Inc. →