ClearanceBrief
Panels › General Hospital › Product code MEA · Class 2

Pump, Infusion, Pca

Regulation 880.5725

0510(k)s in 12 months (31 all time)
0recalls in 12 months (46 all time)
43recalls that name a 510(k)
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Top companies in MEA

DateFirm and productCodeLinked 510(k)
May 7, 2025Smiths Medical ASD, Inc.
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HP
Open, Classified
MEAK170982
May 7, 2025Smiths Medical ASD, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLI
Open, Classified
MEAK072144
K130394 +1
May 5, 2025Smiths Medical ASD, Inc.
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA,
Open, Classified
MEAK170982
Nov 15, 2024Smiths Medical ASD, Inc.
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Open, Classified
MEAK111275
K170982
Aug 3, 2024Smiths Medical ASD Inc.
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidur
Open, Classified
MEAK170982
Aug 3, 2024Smiths Medical ASD Inc.
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into a
Open, Classified
MEAK072144
Feb 7, 2022B Braun Medical Inc
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Terminated
MEAK092313
K172831 +1
Nov 17, 2017CareFusion 303, Inc.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA
Terminated
MEAK032233
Aug 24, 2017Smiths Medical ASD Inc.
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Terminated
MEAK915270
Oct 31, 2016Smiths Medical ASD, Inc.
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Terminated
MEANone listed
Jun 18, 2015Smiths Medical ASD, Inc.
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient sett
Terminated
MEAK072144
K130394
Apr 27, 2015Baxter Healthcare Corp.
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
Terminated
MEAK051253
Apr 23, 2015Hospira Inc.
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
Terminated
MEAK042800
Apr 23, 2015Hospira Inc.
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Terminated
MEAK043256
Nov 1, 2014Smiths Medical ASD, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create
Terminated
MEAK072144
Mar 8, 2013Hospira Inc.
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Terminated
MEAK042800
Mar 8, 2013Hospira Inc.
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the d
Terminated
MEANone listed
Mar 8, 2013Hospira Inc.
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or ho
Terminated
MEAK042800
Mar 8, 2013Hospira Inc.
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, crit
Terminated
MEAK043256
Mar 8, 2013Hospira Inc.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Terminated
MEAK042800
Sep 10, 2012Hospira, Inc.
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hos
Terminated
MEAK043256
Oct 4, 2011Smiths Medical ASD, Inc.
Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitone
Terminated
MEAK072144
Feb 3, 2011Smiths Medical ASD, Inc.
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-211
Terminated
MEAK072144
Sep 3, 2010Stryker Instruments Div. of Stryker Corporation
Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI.
Terminated
MEAK030661
Sep 3, 2010Stryker Instruments Div. of Stryker Corporation
Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI.
Terminated
MEAK030661
Sep 3, 2010Stryker Instruments Div. of Stryker Corporation
Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF 540-428, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments Kalamazoo MI
Terminated
MEAK030661
Mar 11, 2010Smiths Medical ASD, Inc.
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an access
Terminated
MEAK072144
Aug 6, 2008Hospira Inc.
Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each dr
Terminated
MEANone listed
Apr 26, 2006Baxter Healthcare Corp.
Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
MEAK880733
K902613 +2
Apr 26, 2006Baxter Healthcare Corp.
AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
MEAK926385
Apr 26, 2006Baxter Healthcare Corp.
Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
MEAK993387
Apr 26, 2006Baxter Healthcare Corp.
AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
MEAK926385
Apr 26, 2006Baxter Healthcare Corp.
Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
MEAK993387
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1.5 5-Day Infusion Kit; Product number 501-120-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 2-Site Y-Connector; Product number 500-250-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 2-Site Y-Connector; Product number 500-200-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 1-Day Infusion Kit; Product number 500-140-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 2-Day Infusion Kit; Product number 500-120-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000.
Terminated
MEAK042405
Mar 21, 2006Stryker Instruments Div. of Stryker Corporation
Stryker PainPump1 Base Kit; Product number 500-100-000.
Terminated
MEAK042405
Mar 9, 2006Hospira Inc
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
Terminated
MEAK022203
K043256
Aug 16, 2005Baxter Healthcare Corp.
Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R;
Terminated
MEAK031566
Jan 26, 2005Harvard Clinical Technology
Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
Terminated
MEAK033054
Jan 26, 2005Harvard Clinical Technology
Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001
Terminated
MEAK033054

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