510(k) Report

FDA applicant

H&A Mui Enterprises, Inc.

Mississauga, CA2 decisions2020–20230 recalls

FDA records 2 decisions for H&A Mui Enterprises, Inc. (Mississauga, CA) from 2020 to 2023: 2 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and EOB (Nasopharyngoscope (Flexible Or Rigid)). 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, gastroenterology and urology panel, where it files most

How often FDA has decided H&A Mui Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — H&A Mui Enterprises, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • EOBNasopharyngoscope (Flexible Or Rigid)1decision

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?

  • K222587PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc. · 2023
  • K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020

All 2 as H&A Mui Enterprises, Inc. →