Animus Ezserter Infusion Set Inserter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K021700 ↗

FDA Product Code

KZH

Device Class

Class II

Regulation

21 CFR Part 880.6920

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ez Set Infusion Set

  Class II

  FDA 510(k) K012754 Active Cleared 27 Aug 2001

• Ezmanager Max Diabetes Management Software

  Class II

  FDA 510(k) K063674 Active Cleared 30 Mar 2007

• R1000 Series Insulin Pump

  Class II

  FDA 510(k) K993184 Active Cleared 10 Feb 2000

• Model IR 1200 Insulin Pump

  Class II

  FDA 510(k) K032257 Active Cleared 16 Oct 2003

• Ez Manager Max Diabetes Management Software

  Class II

  FDA 510(k) K080587 Active Cleared 15 May 2008

• Symphony Glucose Management System

  Class II

  FDA 510(k) K080639 Active Cleared 24 Jun 2008

See all devices from Animas Corp. →