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)
Top companies in MEA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Smiths 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 |
MEA | K170982 |
| May 7, 2025 | Smiths 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 |
MEA | K072144 K130394 +1 |
| May 5, 2025 | Smiths 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 |
MEA | K170982 |
| Nov 15, 2024 | Smiths 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 |
MEA | K111275 K170982 |
| Aug 3, 2024 | Smiths 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 |
MEA | K170982 |
| Aug 3, 2024 | Smiths 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 |
MEA | K072144 |
| Feb 7, 2022 | B 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 |
MEA | K092313 K172831 +1 |
| Nov 17, 2017 | CareFusion 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 |
MEA | K032233 |
| Aug 24, 2017 | Smiths Medical ASD Inc. Graseby 3300 Pump and Graseby 3000 Series Pump Accessories
Patient controlled syringe pump. Use for Infusion Terminated |
MEA | K915270 |
| Oct 31, 2016 | Smiths Medical ASD, Inc. CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, Terminated |
MEA | None listed |
| Jun 18, 2015 | Smiths 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 |
MEA | K072144 K130394 |
| Apr 27, 2015 | Baxter 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 |
MEA | K051253 |
| Apr 23, 2015 | Hospira 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 |
MEA | K042800 |
| Apr 23, 2015 | Hospira Inc. The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. Terminated |
MEA | K043256 |
| Nov 1, 2014 | Smiths 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 |
MEA | K072144 |
| Mar 8, 2013 | Hospira Inc. LifeCare PCA 3, PCA Serial List Number 12384
Allows for clinician administration or self-administration of analgesic medications. Terminated |
MEA | K042800 |
| Mar 8, 2013 | Hospira 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 |
MEA | None listed |
| Mar 8, 2013 | Hospira 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 |
MEA | K042800 |
| Mar 8, 2013 | Hospira 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 |
MEA | K043256 |
| Mar 8, 2013 | Hospira 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 |
MEA | K042800 |
| Sep 10, 2012 | Hospira, 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 |
MEA | K043256 |
| Oct 4, 2011 | Smiths 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 |
MEA | K072144 |
| Feb 3, 2011 | Smiths 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 |
MEA | K072144 |
| Sep 3, 2010 | Stryker 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 |
MEA | K030661 |
| Sep 3, 2010 | Stryker 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 |
MEA | K030661 |
| Sep 3, 2010 | Stryker 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 |
MEA | K030661 |
| Mar 11, 2010 | Smiths 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 |
MEA | K072144 |
| Aug 6, 2008 | Hospira 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 |
MEA | None listed |
| Apr 26, 2006 | Baxter Healthcare Corp. Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | K880733 K902613 +2 |
| Apr 26, 2006 | Baxter Healthcare Corp. AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | K926385 |
| Apr 26, 2006 | Baxter Healthcare Corp. Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | K993387 |
| Apr 26, 2006 | Baxter Healthcare Corp. AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | K926385 |
| Apr 26, 2006 | Baxter Healthcare Corp. Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | K993387 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 5-Day Infusion Kit; Product number 501-120-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Site Y-Connector; Product number 500-250-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Site Y-Connector; Product number 500-200-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 1-Day Infusion Kit; Product number 500-140-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 2-Day Infusion Kit; Product number 500-120-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000. Terminated |
MEA | K042405 |
| Mar 21, 2006 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump1 Base Kit; Product number 500-100-000. Terminated |
MEA | K042405 |
| Mar 9, 2006 | Hospira Inc Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 Terminated |
MEA | K022203 K043256 |
| Aug 16, 2005 | Baxter Healthcare Corp. Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R; Terminated |
MEA | K031566 |
| Jan 26, 2005 | Harvard Clinical Technology Harvard 2 Syringe Pump manufactured for Rita Medical (OEM)
Model Number 2005-001 Terminated |
MEA | K033054 |
| Jan 26, 2005 | Harvard Clinical Technology Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001 Terminated |
MEA | K033054 |
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