510(k) Report

FDA applicant

Chartermed, Inc.

Lakewood, NJ4 decisions1990–19970 recalls

FDA records 4 decisions for Chartermed, Inc. (Lakewood, NJ) from 1990 to 1997: 4 510(k) clearances. Most are in product codes KPE (Container, I.V.) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 2 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Chartermed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chartermed, Inc. 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?

  • KPEContainer, I.V.3decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K902079Admixture Container for Total Parenteral NutritionChartermed, Inc. · 19901cites it

What has FDA decided for it lately?

  • K973103Chartermed TPN-Eva BagsChartermed, Inc. · 1997
  • K902079Admixture Container for Total Parenteral NutritionChartermed, Inc. · 1990
  • K902464Chartermed Empty TPN Container - 100 ML CapacityChartermed, Inc. · 1990
  • K901753600 or 1200 ML. Enteral Bag Administration SetChartermed, Inc. · 1990

All 4 as Chartermed, Inc. →