510(k) Report

FDA applicant

National Medical Care, Inc.

Rockleigh, NJ2 decisions1997–19970 recalls

FDA records 2 decisions for National Medical Care, Inc. (Rockleigh, NJ) in 1997: 2 510(k) clearances. All are in product code FJK (Set, Tubing, Blood, With And Without…). 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 National Medical Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Medical Care, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — National Medical Care, 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?

  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K971313NMC Hemodialysis Arterial Blood Tubing SetNational Medical Care, Inc. · 19972cite it
  • K971687Hemodialysis Venous Blood Tubing Set or Similar Trade NameNational Medical Care, Inc. · 19971cites it

What has FDA decided for it lately?

  • K971313NMC Hemodialysis Arterial Blood Tubing SetNational Medical Care, Inc. · 1997
  • K971687Hemodialysis Venous Blood Tubing Set or Similar Trade NameNational Medical Care, Inc. · 1997

All 2 as National Medical Care, Inc. →