Atlas FDA

ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

FDA 510(k) clearance K042873 · decided 2004-12-10

Clearance details

K-number
K042873
Device name
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
Applicant
Animas Corp.
Decision
Substantially Equivalent
Date received
2004-10-18
Decision date
2004-12-10
Days to decision
53 days
Clearance type
Traditional
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
West Chester, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuo recall (Z-0993-2013)Animas Corporation2013-04-03
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps In recall (Z-0836-2013)Animas Corporation2013-02-17
Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood g recall (Z-0292-2009)Animas Corporation2008-11-25
Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood recall (Z-0294-2009)Animas Corporation2008-11-25
Isulin Pump. Model IR1250 recall (Z-0309-06)Animas Corporation2005-12-23
Animas IR 1250 Insulin Pump. recall (Z-0929-05)Animas Corporation2005-06-25

PMA approvals by this applicant

RecordFirmDate
Animas Vibe System (P130007/S036)Animas Corp.2018-07-11
Animas Vibe System (P130007/S035)Animas Corp.2018-04-18
Animas Vibe System (P130007/S034)Animas Corp.2018-03-12
Animas Vibe System (P130007/S033)Animas Corp.2018-03-01
Animas Vibe System (P130007/S027)Animas Corp.2017-10-27
Animas Vibe System (P130007/S031)Animas Corp.2017-10-24
Animas Vibe System (P130007/S029)Animas Corp.2017-08-17
Animas, Vibe System (P130007/S026)Animas Corp.2017-06-09