510(k) Report

FDA applicant

Haidylena Medical Egypt

Nasr City, Cairo, EG2 decisions1998–19990 recalls

FDA records 2 decisions for Haidylena Medical Egypt (Nasr City, Cairo, EG) from 1998 to 1999: 2 510(k) clearances. Most are in product codes FJI (Dialyzer, Capillary, Hollow Fiber) and FJK (Set, Tubing, Blood, With And Without…). Its devices cite 1 predicate, 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 Haidylena Medical Egypt’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Haidylena Medical Egypt since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Haidylena Medical Egypt by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FJIDialyzer, Capillary, Hollow Fiber1decision
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K982337Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt · 19981cites it

What has FDA decided for it lately?

  • K982340Extracorporeal Blood CircuitHaidylena Medical Egypt · 1999
  • K982337Cuprophan and Hemophan Hollow Fiber DialyzerHaidylena Medical Egypt · 1998

All 2 as Haidylena Medical Egypt →