510(k) Report

FDA applicant

Animas Corp.

Frazer, PA12 decisions2000–201423 recalls

FDA records 12 decisions for Animas Corp. (Frazer, PA) from 2000 to 2014: 10 510(k) clearances and 2 original PMA approvals. Most are in product codes LZG (Pump, Infusion, Insulin) and MRZ (Accessories, Pump, Infusion). Its devices cite 10 predicates, 3 of them its own earlier devices. 23 recalls are linked to its devices, 1 Class I.

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 Animas Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12008: 22014: 1
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2013

2008: 72009: 22010: 22011: 22012: 32013: 1, 1 Class I
2007high 7 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Animas Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZGPump, Infusion, Insulin7decisions
  • MRZAccessories, Pump, Infusion1decision
  • FPASet, Administration, Intravascular1decision
  • KZHIntroducer, Syringe Needle1decision
  • NCTInstrument, Glucose, Noninvasive Technology1decision
  • OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1decision

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 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.

  • K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 20043cite it
  • K032257Model IR 1200 Insulin PumpAnimas Corp. · 20032cite it
  • K080639Symphony Glucose Management SystemAnimas Corp. · 20082cite it
  • K063674Ezmanager Max Diabetes Management SoftwareAnimas Corp. · 20071cites it
  • K022394Ezmanager PlusAnimas Corp. · 20031cites it

What has FDA decided for it lately?

  • P130007Animas Vibe SystemAnimas Corp. · 20141 recall
  • K080639Symphony Glucose Management SystemAnimas Corp. · 20087 recalls
  • K080587EZ Manager Max Diabetes Management SoftwareAnimas Corp. · 20081 recall
  • K063674Ezmanager Max Diabetes Management SoftwareAnimas Corp. · 2007
  • K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 20041 Class I recall
  • K032257Model IR 1200 Insulin PumpAnimas Corp. · 20037 recalls
  • K022394Ezmanager PlusAnimas Corp. · 2003
  • K021700Animus Ezserter Infusion Set InserterAnimas Corp. · 2002

All 12 as Animas Corp. →

What has been recalled?

23 recalls linked to its devices; the latest:

  • K042873Animas (R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for…Jan 3, 2013Class I
  • K032257Animas (R) 2020, Animas (R) IR 1250 (1200 plus), Animas (R) IR 1200 Insulin Infusion…Dec 17, 2012Class III
  • K032257IR1200, IR1250(IR1200 Plus), 2020 and One Touch (R) Ping (R) Insulin Pump glucose…Jul 16, 2012Class II
  • K080639OneTouch (R) Ping (R) Insulin Pump glucose management system. The device is intended to…Mar 1, 2012
  • P130007Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous…Sep 6, 2011Class II
  • K0322572.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusionFeb 25, 2011