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)

FDA 510(k) clearance K170982 · decided 2017-08-24

Clearance details

K-number: K170982
Device name: 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)
Applicant: Smiths Medical Ads, Inc.
Decision: Substantially Equivalent
Date received: 2017-04-03
Decision date: 2017-08-24
Days to decision: 143 days
Clearance type: Traditional
Product code: MEA
Device class: 2
Regulation number: 880.5725
Medical specialty: General Hospital
Advisory committee: General Hospital
Location: Plymouth, 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.

Record	Firm	Date
ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165)	Summit Medical Products, Inc.	2017-08-29
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
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144)	Smiths Medical MD, Inc.	2008-03-07
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)	Baxter Healthcare Corp	2005-07-15
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 Technology	2003-12-16
MEDLEY PCA MODULE, MODEL 8120 (K032233)	Alaris Medical Systems, Inc.	2003-09-09
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)	Baxter Healthcare Corp	2003-08-19

Record	Firm	Date
CADD Solis HSPCA Pump *Updated 5/27/26* Scope updated to apply specifically to custome recall (Z-1662-2025)	Smiths Medical ASD, Inc.	2025-05-07
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 Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, recall (Z-1681-2025)	Smiths Medical ASD, Inc.	2025-05-05
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 2 recall (Z-0466-2025)	Smiths Medical ASD, Inc.	2024-11-15
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: In recall (Z-2420-2024)	Smiths Medical ASD Inc.	2024-08-03
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302 recall (Z-0963-2023)	Smiths Medical ASD Inc.	2023-01-30