Atlas FDA

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

FDA 510(k) clearance K130394 · decided 2013-12-09

Clearance details

K-number
K130394
Device name
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2013-02-15
Decision date
2013-12-09
Days to decision
297 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
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HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
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Recalls involving this device

RecordFirmDate
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-0 recall (Z-1667-2025)Smiths Medical ASD, Inc.2025-05-07
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Vers recall (Z-1813-2015)Smiths Medical ASD, Inc.2015-06-18

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03