510(k) Report

FDA applicant

East End Medical I, LLC

Miramar, FL2 decisions2021–20240 recalls

FDA records 2 decisions for East End Medical I, LLC (Miramar, FL) from 2021 to 2024: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 3 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided East End Medical I, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — East End Medical I, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC · 20212cite it

What has FDA decided for it lately?

  • K240600SafeCross Vascular Introducer System (4001)East End Medical I, LLC · 2024
  • K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC · 2021

All 2 as East End Medical I, LLC →