510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021439Substantially Equivalent

Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do

Animas Corp., Frazer PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021439 is the FDA 510(k) clearance record for MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO, a class II device, cleared for Animas Corp. on under FDA product code LZG (Pump, Infusion, Insulin). FDA records list 10 510(k) clearances for Animas Corp., from to . As of , FDA records show one recall naming K021439.

Clearance record

Decision date
Received
(23 days to decision)
Product code
LZG Pump, Infusion, Insulin
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Animas Corp. 590 E. Lancaster Ave., Frazer PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZG

Trailing 12 months
2 clearances under product code LZG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260