510(k) Report

FDA applicant

Extracorporeal Medical Specialities, Inc.

Mchenry, IL69 decisions1976–198410 recalls

FDA records 69 decisions for Extracorporeal Medical Specialities, Inc. (Mchenry, IL) from 1976 to 1984: 69 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and FJK (Set, Tubing, Blood, With And Without…). 10 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 Extracorporeal Medical Specialities, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Extracorporeal Medical Specialities, Inc. since 2007.

Recalls per year

1in 2015

2007: 22009: 12011: 12012: 12013: 12014: 12015: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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