510(k) Report

FDA applicant

National Medical Care, Medical Products Div., Inc.

Rockleigh, NJ62 decisions1985–19962 recalls

FDA records 62 decisions for National Medical Care, Medical Products Div., Inc. (Rockleigh, NJ) from 1985 to 1996: 62 510(k) clearances. Most are in product codes KDJ (Set, Administration, For Peritoneal Dialysis…) and FJI (Dialyzer, Capillary, Hollow Fiber). 2 recalls are 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, Medical Products Div., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — National Medical Care, Medical Products Div., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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