Atlas FDA

CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

FDA 510(k) clearance K072144 · decided 2008-03-07

Clearance details

K-number
K072144
Device name
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
Applicant
Smiths Medical MD, Inc.
Decision
Substantially Equivalent
Date received
2007-08-02
Decision date
2008-03-07
Days to decision
218 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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Similar devices under this product code

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

RecordFirmDate
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165)Summit Medical Products, Inc.2017-08-29
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982)Smiths Medical Ads, Inc.2017-08-24
LifeCare PCA Infusion System (K143612)Hospira, Inc.2016-04-08
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (K130394)Smiths Medical Asd, Inc.2013-12-09
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313)B.Braun Medical, Inc.2009-11-04
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)Baxter Healthcare Corp2005-07-15
MEDLEY PCA MODULE, MODEL 8120 (K043299)Alaris Medical Systems, Inc.2004-12-10
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
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800)Hospira, Inc.2004-10-18
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
MEDLEY PCA MODULE, MODEL 8120 (K032233)Alaris Medical Systems, Inc.2003-09-09
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)Baxter Healthcare Corp2003-08-19

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 Pumps, Model 2100. Intended for the following uses: Indicat recall (Z-2419-2024)Smiths Medical ASD Inc.2024-08-03
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
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. recall (Z-0166-2015)Smiths Medical ASD, Inc.2014-11-01
Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and recall (Z-0004-2012)Smiths Medical ASD, Inc.2011-10-04
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder recall (Z-1033-2011)Smiths Medical ASD, Inc.2011-02-03
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for recall (Z-1082-2010)Smiths Medical ASD, Inc.2010-03-11