510(k) Report

FDA applicant

Charter Medical, Ltd.

Lakewood, NJ2 decisions1999–20000 recalls

FDA records 2 decisions for Charter Medical, Ltd. (Lakewood, NJ) from 1999 to 2000: 2 510(k) clearances. Most are in product codes BRZ (Set, Blood Transfusion) and CAK (Microfilter, Blood Transfusion). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Charter Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Charter Medical, Ltd. 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?

  • BRZSet, Blood Transfusion1decision
  • CAKMicrofilter, Blood Transfusion1decision

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 2 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.

  • K000685Charter Medical Neonatal Syringe SetCharter Medical, Ltd. · 20002cite it

What has FDA decided for it lately?

  • K000685Charter Medical Neonatal Syringe SetCharter Medical, Ltd. · 2000
  • K990310Charter Medical, LTD MP 450 (40 Micron Filter)Charter Medical, Ltd. · 1999

All 2 as Charter Medical, Ltd. →