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) |
|---|---|---|---|
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:
Single day Infusor 2 ml/h,
Single Day INFUSOR 2 ml/h System,
Half Day INFUSOR SV 5 ml/h System,
Two Day INFUSOR 2 ml/h Terminated |
FRN | K884505 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Basal/Bolus Infusor.
Indicated for the intravenous administration of medications. Terminated |
FRN | K884505 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: SV Elastomeric Infusion Device.
Indicated for the intravenous administration of medications. Terminated |
FRN | K910425 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Intermate Infusion Pump.
Indicated for the intravenous administration of medications. Terminated |
FRN | K910425 |
| Apr 30, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K083019 |
| Apr 30, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K060806 |
| Apr 26, 2013 | Hospira Inc. GemStar Pump - Battery
Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is r Terminated |
FRN | K060806 K083019 |
| Apr 26, 2013 | Hospira Inc. GemStar Pump - Battery
Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is Terminated |
FRN | K060806 K083019 |
| Apr 15, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K060806 K083019 |
| Apr 15, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | K060806 K083019 |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | K051641 |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage:
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System Terminated |
FRN | K051641 |
| Mar 26, 2013 | Smiths Medical ASD, Inc. Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500.
Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Terminated |
FRN | K040899 |
| Mar 8, 2013 | Hospira Inc. The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including Terminated |
FRN | K912928 |
| Feb 5, 2013 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Terminated |
FRN | K110901 |
| Feb 5, 2013 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Terminated |
FRN | K110901 |
| Feb 4, 2013 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids
Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr Terminated |
FRN | K110901 |
| Feb 4, 2013 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids
Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nut Terminated |
FRN | K110901 |
| Feb 4, 2013 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids
Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr Terminated |
FRN | K041550 K110901 |
| Feb 4, 2013 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids
Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr Terminated |
FRN | K041550 K110901 |
| Dec 31, 2012 | B. Braun Medical, Inc. Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130.
The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. Terminated |
FRN | K062700 K083689 |
| Dec 31, 2012 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric t Terminated |
FRN | K081412 |
| Dec 31, 2012 | Hospira Inc. Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software ve Terminated |
FRN | K021350 K042081 +1 |
| Dec 31, 2012 | Hospira Inc. Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 Terminated |
FRN | K011442 K042081 +2 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion Pump
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly Terminated |
FRN | K073051 |
| Dec 7, 2012 | Hospira Inc. Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet soft Terminated |
FRN | K042081 |
| Dec 7, 2012 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNe Terminated |
FRN | K081412 |
| Dec 7, 2012 | Hospira Inc. Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module li Terminated |
FRN | K011442 K031185 +3 |
| Nov 28, 2012 | Iradimed Corporation The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set.
Labeling indicates ~10 ml, Latex-free Infusio Terminated |
FRN | K050301 |
| Oct 19, 2012 | Hospira Inc. Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01
Device is a general p Terminated |
FRN | K041550 K110901 |
| Oct 19, 2012 | Hospira Inc. Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01
Device is a general p Terminated |
FRN | K041550 K110901 |
| Oct 17, 2012 | MOOG Medical Devices Group ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO,
The Curlin Ambulatory Infusion Pump System with disposab Terminated |
FRN | K981816 |
| Oct 12, 2012 | Belmont Instrument Corporation Belmont Rapid Infuser, a Fluid Management System,
Model FMS2000. Terminated |
FRN | K032674 K091855 +1 |
| Aug 24, 2012 | Baxter Healthcare Corp. Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R.
Product Usage: Terminated |
FRN | K930459 |
| Aug 24, 2012 | Baxter Healthcare Corp. Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump;
Product Usage: These product codes includes refurbished units. Intended for the controlled rate d Terminated |
FRN | K930459 |
| Aug 17, 2012 | CareFusion 303, Inc. Alaris Pump Module Model 8100 (formerly Medley Pump Module)
Subsequent Product Code: FPA.
The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, bl Terminated |
FRN | K950419 |
| Aug 15, 2012 | CareFusion 303, Inc. Alaris Pump Module model 8100.
Subsequent product code: FPA
The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using Terminated |
FRN | K950419 |
| Aug 1, 2012 | Smiths Medical ASD, Inc. Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.
Designed for use Terminated |
FRN | K111386 |
| Jul 26, 2012 | CareFusion 303, Inc. Alaris PC unit model 8015
Product Usage: The device is labeled for prescription use only. Terminated |
FRN | K051641 |
| Jul 18, 2012 | Sigma SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software.
Product Usage:
A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. Terminated |
FRN | K042121 |
| Jul 16, 2012 | B. Braun Medical, Inc. Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102.
Intended for use with adults, pediatrics Terminated |
FRN | K062700 K083689 |
| Jun 13, 2012 | Baxter Healthcare Corporation Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103
Terminated |
FRN | K042121 |
| May 4, 2012 | Hospira Inc. LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number Terminated |
FRN | K865060 |
| Apr 26, 2012 | Hospira Inc. GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027 Terminated |
FRN | K023062 K042980 +3 |
| Apr 13, 2012 | MOOG Medical Devices Group Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user access Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter ASV Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user access Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Needleless Injection Port Positive Pressure Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administra Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-Vented Bag Spike, Microbore tubing w/free-flow protection, slide clamp ASV
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provid Terminated |
FRN | None listed |
| Apr 13, 2012 | MOOG Medical Devices Group Non-DEHP Epidural Administration Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged Assembly
The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and use Terminated |
FRN | None listed |
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