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 19, 2017 | CareFusion 303, Inc. Alaris Pump Module model 8100 Terminated |
FRN | K950419 |
| Jun 19, 2017 | CareFusion 303, Inc. Alaris PC Unit, Model 8015 Terminated |
FRN | K051641 |
| Jun 15, 2017 | ICU Medical Inc Plum 360 Infusion System Terminated |
FRN | K141789 K161469 |
| Jun 5, 2017 | Smiths Medical ASD Inc. CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc. Terminated |
FRN | K843772 |
| Jan 26, 2017 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 Terminated |
FRN | K133801 |
| Jan 18, 2017 | CareFusion 303, Inc. Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221.
The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module Terminated |
FRN | K950419 |
| Dec 30, 2016 | Hospira Inc., A Pfizer Company Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions Terminated |
FRN | K141789 |
| Nov 11, 2016 | Bayer Healthcare PET Infusion Pump Terminated |
FRN | K080297 K100798 |
| Nov 7, 2016 | Bayer Healthcare MEDRAD Intego PET Infusion System - Pump
Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclea Terminated |
FRN | None listed |
| Nov 1, 2016 | CareFusion 303, Inc. Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. Terminated |
FRN | K051641 |
| Sep 28, 2016 | Baxter Healthcare Corp. V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in Terminated |
FRN | K133801 |
| Sep 28, 2016 | Baxter Healthcare Corp. Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporatio Terminated |
FRN | K133801 |
| Sep 28, 2016 | Baxter Healthcare Corp. sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Me Terminated |
FRN | K042121 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | K081412 |
| Sep 6, 2016 | Hospira Inc. Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr Terminated |
FRN | K081412 |
| Aug 8, 2016 | CareFusion 303, Inc. Alaris Syringe Module Model 8110 with software version 9.15
The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps Terminated |
FRN | K023264 |
| Jul 28, 2016 | Hospira Inc., A Pfizer Company Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump
Hospira MedNet Medication Managemen Terminated |
FRN | K141102 |
| Jul 18, 2016 | WalkMed Infusion, LLC The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Terminated |
FRN | K070529 |
| Jul 18, 2016 | WalkMed Infusion, LLC The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Terminated |
FRN | K070529 |
| May 12, 2016 | CareFusion 303, Inc. Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19;
Central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | K051641 |
| Mar 25, 2016 | Hospira Inc. The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, seco Terminated |
FRN | K141789 |
| Mar 25, 2016 | Hospira Inc. The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad Terminated |
FRN | K141789 |
| Mar 24, 2016 | CareFusion 303, Inc. Alaris PC unit, Model 8015
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | K051641 |
| Feb 11, 2016 | MOOG Medical Devices Group Moog Curlin Infusion, Ambulatory Infusion Pump
The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps.
Curlin 4000, catalog number 340; Curlin 6000, 6000 Terminated |
FRN | K981816 |
| Jan 11, 2016 | Bayer Healthcare Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. Terminated |
FRN | K100798 |
| Dec 22, 2015 | Hospira Inc. The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in o Terminated |
FRN | K110901 |
| Nov 6, 2015 | WalkMed Infusion, LLC Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner. Terminated |
FRN | K070529 |
| Aug 20, 2015 | Elite Biomedical Solutions LLC Alaris Medley LVP Bezel Assembly.
Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 Terminated |
FRN | None listed |
| Aug 20, 2015 | Elite Biomedical Solutions LLC Alaris Medley LVP Frame Membrane.
Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 Terminated |
FRN | None listed |
| Aug 14, 2015 | CareFusion 303, Inc. Alaris Syringe Pump, Model No. 8110. Delivers fluids.
Expansion of Affected Units:
BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100. Terminated |
FRN | K023264 |
| Jul 24, 2015 | Medtronic MiniMed Inc. MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. Terminated |
FRN | None listed |
| Jun 16, 2015 | CareFusion 303, Inc. Alaris PC unit model 8015, Infusion pump. software version 9.17
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software Terminated |
FRN | K051641 |
| Apr 16, 2015 | Baxter Healthcare Corp Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2
The SIGMA Spectrum Infusion Pump with Mas Terminated |
FRN | K133801 |
| Mar 23, 2015 | CareFusion 303, Inc. Alaris PC units, Model No. 8015. Infusion pump. Terminated |
FRN | K051641 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K052052 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K081412 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K042081 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K070398 |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | K011442 |
| Feb 19, 2015 | CME America, LLC BodyGuard 323 pump, models
100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS,
100-603XSA and 100-603XSAP Terminated |
FRN | K042696 |
| Feb 4, 2015 | Hospira Inc. Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and Terminated |
FRN | K042081 |
| Nov 24, 2014 | Hospira Inc. GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088.
Product Usage
The pump is suitable for intravenous, arterial, subcutaneous, short-term Terminated |
FRN | K060806 |
| Nov 24, 2014 | Hospira Inc. GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150.
Product Usage
The pump is suitable for intravenous, arterial, subcutaneous, short-term Terminated |
FRN | K060806 |
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