Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Hospira Inc Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA Terminated |
FRN | K041550 |
| Aug 11, 2009 | Hospira Inc Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA. Terminated |
FRN | K041550 |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015;
Alaris Pump Module, Model 8100;
Alaris Patient-Controlled Analges Terminated |
FRN | K012383 K023264 +3 |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health Alaris Pump Module, Model 8100. Terminated |
FRN | K950419 |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009).
The Alaris PC Unit is the central programming and power supply component for the Alaris System modules. Terminated |
FRN | K051641 |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120).
The Alaris PC Unit is the central programming Terminated |
FRN | K012383 K051641 |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above. Terminated |
FRN | K012383 K051641 |
| May 1, 2009 | Cardinal Health 303 dba Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Terminated |
FRN | K012383 K032233 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 541-155.
The Stryker PainPump2 is an electromechani Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-350.
The Stryker PainPump2 is an electromechanical pump designed to deliver a control Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-50.
The Stryker PainPump2 is an electromechanical pump designed to deli Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-25.
The Stryker PainPump2 is an electromechanical pump designed to deli Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 521-155.
The Stryker PainPump2 is an electr Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 521-125.
The Stryker PainPump2 is an electr Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-155.
The Stryker PainPump2 is an electromechani Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-50.
The Stryker PainPump2 is an electromechanical pump designed to deli Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-25.
The Stryker PainPump2 is an electromechanical pump designed to deli Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-350.
The Stryker PainPump2 is an electromechanical pump designed to deliver a control Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-158.
The Stryker PainPump2 is an electromechanical pump d Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-155.
The Stryker PainPump2 is an electromechani Terminated |
FRN | K043466 |
| Apr 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-125.
The Stryker PainPump2 is an electromechani Terminated |
FRN | K043466 |
| Apr 7, 2009 | Cardinal Health 303 dba Cardinal Health ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167.
Intended for self-administration of anti-microbial and antiviral agents. Terminated |
FRN | K895797 K913658 |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | K040899 |
| Mar 9, 2009 | Smiths Medical MD, Inc. Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump.
The Medfusion 3500 syringe pump is indicated for use w Terminated |
FRN | K040899 |
| Mar 2, 2009 | Baxter Healthcare Corp. Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product codes: 2M8153, 2M8163, Terminated |
FRN | K063696 |
| Mar 2, 2009 | Baxter Healthcare Corp. Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, Terminated |
FRN | K063696 |
| Feb 27, 2009 | Hospira Inc Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA.
Is a general pur Terminated |
FRN | K041550 |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-200-000, REF 500-200.
A disposable syringe infuser which uses su Terminated |
FRN | K042405 |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-166-050, REF 500-166-50.
A d Terminated |
FRN | K042405 |
| Feb 2, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25.
A Terminated |
FRN | K042405 |
| Jan 27, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000.
The device is used to deliver controlle Terminated |
FRN | K043466 |
| Oct 21, 2008 | Baxter Healthcare Corp. Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
Indicated for infusion via intravenous, intra-arte Terminated |
FRN | K945942 |
| Sep 23, 2008 | B. Braun Medical, Inc. Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Out Terminated |
FRN | K904518 K921860 |
| Sep 23, 2008 | B. Braun Medical, Inc. Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Saf Terminated |
FRN | K904518 K921860 +1 |
| Sep 23, 2008 | B. Braun Medical, Inc. Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product i Terminated |
FRN | K904518 K921860 +1 |
| Sep 23, 2008 | Smiths Medical MD, Inc. Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.
Reorder number 21-5311-01
The product is used for gene Terminated |
FRN | K940446 |
| Sep 23, 2008 | Smiths Medical MD, Inc. Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK.
Reorder numbers 21-5301-01 & 21-5306-01
The product is us Terminated |
FRN | K940446 |
| Sep 22, 2008 | Curlin Medical Llc PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 Terminated |
FRN | K981816 |
| Sep 22, 2008 | Curlin Medical Llc Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 Terminated |
FRN | K981816 |
| Sep 22, 2008 | Curlin Medical Llc Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101 Terminated |
FRN | K981816 |
| Sep 22, 2008 | Curlin Medical Llc Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001 Terminated |
FRN | K981816 |
| Sep 22, 2008 | Curlin Medical Llc Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001 Terminated |
FRN | K981816 |
| Aug 24, 2008 | Smiths Medical MD, Inc. CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication.
Reorder Numbers Terminated |
FRN | K051568 |
| Aug 15, 2008 | Smiths Medical MD, Inc. CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care p Terminated |
FRN | K051568 |
| Jun 10, 2008 | Cardinal Health 303 Inc DBA Alaris Products U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005:
(1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe mod Terminated |
FRN | K010966 K012383 +4 |
| Jun 10, 2008 | Cardinal Health 303 Inc DBA Alaris Products Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Uni Terminated |
FRN | K010966 K012383 +4 |
| Jun 10, 2008 | Cardinal Health 303 Inc DBA Alaris Products U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130 Terminated |
FRN | K012383 K950419 |
| Feb 26, 2008 | Smiths Medical MD, Inc. Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator
REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA Terminated |
FRN | K062892 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
| Feb 13, 2008 | Smiths Medical MD, Inc. Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112 Terminated |
FRN | K843772 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.